biosystems BA 400 Service Manual

page of 132

/ 132
Bookmarks

Quick Links

Download this manual

ervice

anual

Need help?

Do you have a question about the BA 400 and is the answer not in the manual?

Questions and answers

Summary of Contents for biosystems BA 400

Page 1 ervice anual...
Page 3 Manual version Revision date Change June 2012 Initial version Manual code TESE000012-01-ING Manufacturer's address BIOSYSTEMS c/Costa Brava 30, 08030 Barcelona SPAIN http://www.biosystems.es The BA400 analyser is compliant with European Union directive 98/79/EC...
Page 5 TABLE OF CONTENTS Persons for whom this manual is intended ..............8 Notices and warnings ....................8 Software usage licence ....................12 Foreseen use ........................13 Introduction....................13 General description of the analyser..............14 Sample rotor......................... 14 2.1. Reagent rotor........................ 14 2.2. Reaction rotor.
Page 6 Service Manual 6.1.4. Description of the status icons................... 68 Programme initialisation....................69 6.2. Description of the menus....................69 6.3. Setup........................... 70 6.4. 6.4.1. Analyser........................70 6.4.2. Communications..................... 71 6.4.3. Language........................ 72 6.4.4. Barcode........................72 6.4.5. Users........................72 Adjustments/Test......................73 6.5. 6.5.1. Adjust positioning....................73 6.5.1.1. Optical centring adjustment ......................73 6.5.1.2. Wash station adjustment ......................74 6.5.1.3. Adjusting the arm positioning .
Page 7 Dismantling of elements................97 Dismantling of housing....................97 8.1. 8.1.1. Removing the rear cover.................... 97 8.1.2. Removing the top cover.................... 97 8.1.3. Removing the side housings..................97 8.1.4. Dismantling and assembling the ISE cover..............98 8.1.5. Remove the top front housing..................99 8.1.6. Dismantling the top tray..................100 Remove the sample and reagent arms and the stirrers............100 8.2. Dismantling the reagent rotor..................
Page 8 Service Manual Persons for whom this manual is intended This manual is intended for professionals belonging to the technical service who perform preventive maintenance tasks on and repair the BA400 analyser. These professionals will have received special training enabling them to perform the above-described tasks. This manual describes the mechanical and electronic characteristics and service software to assist technicians in performing maintenance and repair work. It also describes the steps for dissassembling and changing the different elements that comprise the analyser. Notices and warnings Explanation of the safety symbols located on the analyser or in this manual. Symbol Description The symbol warns of operating risks that could cause personal injury. WARNING The symbol warns of a potential biological hazard. BIOHAZARD The symbols warns of potential damage to the system or unreliable results. CAUTION The symbol warns that the information requires your attention. NOTE Risk of electric shock The symbol warns of a potential risk due to laser radiation emission Explanations of the symbols used on the analyser labels and in the manual Symbol Description This product is compliant with EC directive 98/79/on medical devices for In Vitro Diagnostics.
Page 9 Symbol Description Medical device for In Vitro Diagnostics Please consult the directions for use Serial number Expiry date Batch code Catalogue number Temperature limit Manufacturer Irritant Safety precautions Symbol Description Preventing electric shock To prevent the risk of electrocution. Do not remove any of the analyser housing elements. No user intervention makes it necessary to access the parts inside the equipment. If necessary, contact the technical assistance service. Preventing biological risks in handling the samples Inappropriate handling of samples, controls and calibrators could cause biological infection. Do not touch the samples, mixtures or waste with your hands. Wear gloves and protective clothing when necessary. BIOHAZARD In the event that the samples come into contact with the skin, wash immediately with abundant water and seek medical advice. It is advisable to follow best laboratory practices. Prevention in handling reagents Handle reagents and washing solutions with care, they contain substances that could be corrosive. In the event that the reagents or washing solutions come into contact with the WARNING skin, wash immediately with abundant water and in the event of a reaction,...
Page 10 Service Manual Symbol Description Preventing biological risks in handling liquid waste Handle the high contamination waste container with care. Wear gloves and protective clothing when handling the container. Dispose of the waste in accordance with national or local legislation for BIOHAZARD disposing of dangerous biological waste, and consult the reagent manufacturer or distributor for more details. Preventing biological risks in handling solid waste Take care in handling parts of the analyser that are converted to waste such as the reactor rotor, sample tubes and reagent bottles. Wear gloves and protective clothing when handling such waste. BIOHAZARD Dispose of the waste in accordance with national or local legislation for disposing of dangerous biological waste, and consult the reagent manufacturer or distributor for more details. Prevention of electro magnetic interferences The analyser complies with the requirements with respect to emissions and immunity set forth in the standard UNE -EN 61326-2-6:2006. This equipment has been designed and tested for class B of standard UNE-EN NOTE 55022:2000. In a household environment, it may cause radio interference, in which case the necessary measures must be taken to mitigate such interference.
Page 11 Abbreviation Definition Fuse Ion-selective electrode In Vitro Diagnostics LED lamp Light-emitting diode Laboratory information system WEEE Waste Electrical and Electronic Equipment Reference solution for the ISE unit Technical assistance service Standard deviation Electrical safety Ultraviolet Units Definition “ Inch ˚ C Degrees centigrade Ampere / Absorbance Gigabyte Time Hertz Kilogram Litre Megabyte Metre Minute Millilitre Millimetre mmol Millimol Millivolt Nanometre prep Preparation Second Volt-ampere Volt Watt μL...
Page 12 Service Manual Software usage licence BioSystems, S.A., the exclusive owner of all the rights over this computer application, grants one non-transferable, non-exclusive licence governing the use of the computer application to the user, who accepts it solely and exclusively for executing this computer application in a single central processing unit (CPU) of a computer. This licence does not permit the execution, use, access, reproduction, transformation, translation, lease, sale, distri- bution, commercial exploitation or provision to third parties in any way, and above all in a computer network or through remote access technologies, of all or part of the content included in this CD-Rom. BioSystems, S.A. will in no case be liable or assume payment of any compensation whatsoever: with respect to any infringement of the intellectual and/or industrial property rights of others caused by copying images, audio and/or text as part of the content of this CD-Rom; due to the exhaustiveness or accuracy of the data incorporated through incorrect use of the computer application in the CD-Rom; for damages, losses or indirect, special, incidental or consequential damages to people or property due to the incor- rect use or putting into practice of any of the methods, theories, products, instructions, ideas or recommendations included in this CD-Rom or which make reference to its content. The computer application in this CD-Rom is delivered with no guarantee of the results obtained following incor- rect use or adaptation for a specific purpose. The user fully assumes all risks with regard to the results obtained by incorrect use of the computer application. None of the contents of this usage licence grants the user any intellectual or industry property rights or any right over the confidential information of BIOSYSTEMS and/or of persons holding rights over the content included in this CD-Rom. The licence granted and constituted pursuant to these terms and conditions will be interpreted in accordance with and governed by Spanish law, with the jurisdiction being the courts of the city of Barcelona, Spain. The user waives any other applicable legislation and/or jurisdiction that is competent, if any. The user of this licence knows and agrees that the user licence grants no rights over the use of computer programmes and/or applications belonging to others that may be used or which may be necessary for using or operating this computer application, for which the user will obtain the respective legitimisation of use.
Page 13 Foreseen use The BA400 analyser is used to determine analyte concentrations by in vitro biochemical, turbidimetric and electrolyte measurements of human samples of serum, urine, plasma, cephalorachidian fluid or total blood. The analyser is exclusively for professional use, i.e., for users who have the appropriate training and expertise to use it. In addition to how to install the instrument, users are instructed on how to use the analyser and the software that goes with it. The environmental conditions for the functioning of the analyser are normal clinical analysis laboratory conditions. These conditions are described in the specifications chapter. 1. Introduction The BA400 analyser is a random-acess, automatic analyser that makes readings at a rate of 400 prep/h. It is specifi- cally designed for performing clinical biochemical and turbidometric analyses and for electrolyte readings. Control of the instrument is performed on-line in real time from a dedicated external PC. The analyser has 5 arms: 2 arms for handling reagents, 1 arm for handling samples and 2 arms for stirring the reagent and sample mixture. There are two rotors, with the reagents being positioned in one and the samples in the other. The reagent rotor is refrigerated and both rotors have barcode readers. The reagent and sample are mixed in the third rotor or reaction rotor. It is also where the photometric readings are taken while the reaction develops. The reaction rotor is thermostatted and has a wash station for emptying the completed reactions and for washing and drying the cuvettes for the next preparation round. It therefore processes a continuous flow of preparations. The analyser has the following built-in safety elements: vertical arm collision detector, sample tip clot detector and detectors in all the covers.
Page 14 Service Manual 2. General description of the analyser In mechanical terms, the analyser is divided up into subassemblies. Each subassembly has its own electronic board for controlling the individual subassembly elements. All the subassemblies are electrically connected by the CAN bus cable. The CAN bus cable contains the power wires and the wires that transmit information between the boards. A list of the subassemblies is given below: • Sample rotor • Reagent rotor • Reaction rotor • Pipetting arm • Stirring arm • Wash station • Dispensing pumps • Fluidic system • Washing solution and high contamination waste bottles • Electrical and communication connections • ISE module (optional) 2.1. Sample rotor The sample rotor is comprised of a drum for positioning the samples, a cover and a barcode reader. The drum has a circular structure with 3 concentric rings in which the tubes or sample wells are placed. Each of the 3 rings has 45 positions for tubes with diameters of between 12 and 16 mm and heights of up to 100 mm The barcode reader can only read the primary tubes with codes located in the two outer rings.
Page 15 Both 60 mL and 20 mL bottles can be placed in the inner ring. The rotor is refrigerated, and the mean temperature inside it is below 8degrees C. The fridge has an independent power supply system with its own switch so that when the analyser is switched off, the fridge can continue to operate. 2.3. Reaction rotor The reaction rotor has 120 positions and a cover. The whole assembly is refrigerated. The rotor is a single part made of PMMA and has 120 positions. The sample and reagent mixture reactions are performed on it. Different optical readings are taken during the reaction. The PMMA material filters UV radiation. The rotor is maintained at a stable temperature of 37 degrees C by a Peltier-based thermostatting system. The reaction volumes range is from 200 μL to 600 μL. Each arm dispenses in a different position from the rotor. The dispensing positions are: • Cycle 1: R1 dispensation • Cycle 31: S dispensation (sample) • Cycle 32: R1+S stirring • Cycle 33: Initiation of photometric readings • Cycle 66: R2 dispensation and stirring of reagent 2 • Cycle 100: End of the reading processes • Cycles 101 –111: Elimination of the completed reaction and cleaning of the sample well in the wash station. 2.4. Optical system The optical system is located in the reaction rotor, below the wash station. It is formed by a set of leds, filters, beam splitters, the reaction rotor and two photodiodes. There is one principal reading diode and a reference photodiode that enables the correction of perturbations gener- ated in the light source The analyser has 8 wavelengths: 340, 405, 505, 535, 560, 600, 635, 670 The measuring range is from -0.2 Abs to 3.5 Abs. The measuring resolution is 0.0001 Abs. The system automatically performs a blank on the cuvette before dispensing the reagent. This blank absorbance value is used to correct the absorbance values measured in the cuvette. If this value exceeds a preestablished limit, the cuvette is discarded. 2.5.
Page 16 Service Manual • Cycle 4: Suctioning of the washing solution and dispensing of distilled water • Cycles 5 and 6: Suctioning and dispensing of distilled water • Cycle 7: Distilled water rest phase • Cycle 8: Optical scanning of cuvette • Cycle 9: Suctioning of distilled water • Cycle 10: Drying of cuvette The distilled water for rinsing and the washing solution are thermostatted so that they do not interfere with the rotor temperature. When the last rinse is made, an optical reading is taken of the rotor sample well, in order to verify the state of the well. If it is scratched or in poor condition, the well is discarded and not used for performing reactions. In the event of there being a large number of wells in poor condition, the programme warns that the reaction rotor needs to be replaced. 2.6. Waste, distilled water and washing solution containers The analyser has 4 containers for storing waste, distilled water and washing solution. These containers are located inside it. The high contamination waste and washing solutions containers can be accessed from the front. The capacity of both containers is 5 L. This capacity allows for 8 hours of continuous autonomous operation. Detection of whether the bottle is full or empty is done by weighing. The low contamination waste and distilled water containers are located inside the analyser, at the rear, and cannot be accessed by the user. These containers have a buoy system that informs the analyser when they are full or empty. They are automatically filled and emptied from the exterior. The external distilled water inlet may come from a pressurised distilled water inlet or an external tank with a larger capacity. The low contamination waste leaves the appliance through a drainage pipe that goes directly to a tank or sump. 2.7. Stirring arm The analyser has two arms for stirring the reaction. These arms have a small blade that rotates inside the reaction cuvettes, to ensure the proper mixing of the reagent and sample.
Page 17 • R1 reagent arm: from 150 μL to 500 μL • R2 reagent arm: from 40 μL to 300 μL Each arm has a tip with an automatic level detection system. The tip descends until it reaches the reagent or sample, depending on the case, and then suctions the programmed volume. This prevents the tip from penetrating too deeply in the fluid and makes it easier to wash the tip. Each arm has a vertical collision detection system to prevent the tips from colliding with each other and ensure they are not damaged. The sample dispensing arm has a clot detector. This system warns the user if the tip becomes blocked when suction- ing the sample. The blockage may be due to traces of fibrin or clotting present in the serum sample. 2.9. ISE module (optional) The ISE ion module is optional, and is used to determine Na , Cl and Li ions in serum and urine samples. The ion module is fully autonomous and functions in parallel, together with the biochemical determinations. When ISE ion testing of patients is programmed in the list, the sample-dispensing arm is responsible for positioning the sample in the ion module. The module has a fully sealed kit that contains the calibration standards and collects the waste. This kit is an acces- sory and its compartment is accessible from the front part of the analyser. 2.10. Operating mode The analyser performs the tests patient by patient and permits the continuous input of samples. The analyser is controlled by a dedicated PC that is in permanent communication with the instrument. The application programme installed in the computer keeps the user constantly informed about the state of the analyser and the progress of the tests. As the results are obtained, the computer immediately displays them to the user. When starting a Worksession, the analyser proposes the performing of the blanks, calibration standards and controls programmed for the measuring procedures it must execute. The user can decide whether or not to execute the blanks and calibration standards. If they are not executed, the analyser will use the latest data available. The controls can also be activated or not activated. During a worksession, while the analyser is operating, the user can enter new routine or urgent samples for analysis. Every time a new sample is added, the analyser automatically proposes potential new blanks, calibration standards or controls that must be executed. It is advisable to restart the session each working day. The analyser determines the concentrations of the analytes based on optical absorbance measurements. To measure the concentration of an analyte in a sample, the analyser pipettes a specific volume of reagent, thermostats it in the same tip and dispenses it into the reaction rotor. After 5 minutes the analyser pipettes a specific sample volume and dispenses it into the same well in which the reagent was dispensed.
Page 18 Service Manual 3. Mechanical elements In mechanical terms, the analyser has a tubular structure to which the different subassemblies and housing elements are attached. The analyser has the following subassemblies: • Sample rotor • Reagent rotor • Reaction rotor • Pipetting arms • Stirring arms • Wash station • Dosing system • Fluidic system • ISE module (optional) 3.1. Sample rotor The tubes with the patient serum samples and the wells with the calibration standards and controls are placed in the sample rotor. The rotor (3) has 3 rings. Tubes with larger diameters (16 mm) are placed directly in the holes. Tubes with smaller diameters or sample wells require the use of adapters (2) to secure them in place. Figure 3.1 Sample rotor assembly The rotor (3) has a single position once it has been inserted into its compartment (4). For this reason it has a cen- tring device (6) to guide it. Once inserted, the rotor cannot be removed as it is blocked by a ball-shaped anchoring device (7). To release the rotor from the base it is necessary to press the button (5). The rotor vessel (9) is secured to the rotor assembly support (10). The rotor (3) is connected to the rotor centring device, which in turn is connected to the pulley by a shaft (14). The belt (13) transmits the motor movement (11) to the whole assembly.
Page 19 The start-up sensor (12) ensures the initial position of the sample rotor by means of a tab on the pulley. The vessel exterior is protected by a cover (1). A Hall effect sensor (8) indicates that the cover is on the analyser. References of figures 3.1, 3.2 and 3.3: 13 – Transmission belt 1 – Sample rotor cover 14 – Pulley 2 – Adapters for tube and sample well 15 – Barcode reader protective window 3 – Sample rotor 16 – Barcode reader 4 – Rotor assembly 17 – CIIM00052 electronic board 5 – Rotor anchoring button 18 – Set screw for angular orientation of barcode reader 6 – Rotor positioning device 19 – Set screw for adjusting the barcode reader height 7 – Rotor ball-shaped anchorages 20 – Set screw for barcode reader proximity adjustment 8 – Cover sensor 9 – Rotor vessel 10 – Rotor assembly support 11 – Rotor circular movement motor 12 – Rotor start-up sensor Figure 3.2 Detail of sample rotor assembly The barcode reader (16) is secured by a support to the subassembly structure. It is positioned at the correct height for the light to correctly illuminate the tubes placed in the rotor. There is a protective window to isolate the reader from the exterior. The barcode reader position can be adjusted using mechanical means. See chapter 6 for applying the service programme and reader adjustment, and Figure 3.3. • To adjust the angular orientation, loosen the screws (18) and move the reader with your hand until you obtain a correct reading. Tighten the screws (18). • To adjust the reader height, loosen the screws (19) and move the reader upward or downward with your hand. Once the readings are correct, tighten the screws (19).
Page 20 Service Manual Figure 3.3 Barcode reader adjustment 3.2. Reagent rotor The reagent bottles are placed in the reaction rotor. There are two types of bottle, one containing 60 mL and one containing 20 mL. The rotor (3) has 2 rings. Only 20mL bottles can be placed in the outer ring, and both 20mL and 60mL bottles can be placed in the inner ring. The assembly has a barcode reader that reads the codes on the bottles placed in both rings. The whole assembly is refrigerated and has a separate power supply system to maintain the refrigeration when the appliance is turned off. Figure 3.4 Sample rotor assembly The rotor transmission system and the barcode reader support and adjustment are exactly the same as those of the sample rotor. See chapter 3.1, description of the transmission system and barcode reader support. The reagent rotor compartment is refrigerated. To maintain the temperature, the vessel is protected by an insulator (8). The cooling system is performed by 4 peltiers (10) that cool the vessel through the copper splitters (9). The heat produced by the peltiers is evacuated through the radiators (11) and fans (12).
Page 21 References of figures 3.4 and 3.5: 7 – Rotor ball-shaped anchorages 1 – Reaction rotor cover 8 – Insulator 2 – 60mL and 20mL reagent bottles 9 – Peltier splitter 3 – Reagent rotor 10 – Peltier 4 – Rotor assembly 11 – Radiator 5 – Rotor anchoring button 12 – Fan 6 – Rotor positioning device Figure 3.5 Reagent rotor cut-off 3.3. Reaction rotor The reaction rotor is the place where the sample is mixed with the reagent. The rotor (2) has 120 PMMA wells. The rotor is installed in a heating canal (3) thermostatted at 37 degrees.C. The entire assembly is protected by a cover (1), to maintain the temperature inside it and prevent light from entering. The system functions continuously and for this purpose, it has a wash station (4) which empties and washes the rotor wells in 10 cycles. During each cycle, the analyser reads 68 wells with the optical system (5) that is built into the assembly. Figure 3.6 Reaction rotor assembly...
Page 22 Service Manual Figure 3.7 Reaction rotor cut-off Figure 3.8 Reaction rotor transmission assembly References of figures 3.6, 3.7 and 3.8: 11 – Radiator 1 – Reaction rotor cover 12 – Fan 2 – Reaction rotor 13 – Reading encoder 3 – Heating canal 14 – Transmission wheel 4 – Wash station 15 – Rotor motor operation 5 – Optical system 16 – Motor pinion 6 – Heating canal insulator 17 – Transmission belt 7 – Rotor anchoring bolt 18 – Encoder photosensor 8 – Rotor centring device 19 – Rotor assembly support column 9 – Rotor start-up sensor 10 – Peltier...
Page 23 The methacrylate rotor (2) is centred by means of tabs with a size that is different to that of the rotor centering device (8) and secured firmly by a bolt (7). The initiation photosensor (9) detects the initial position of the rotor. The heating canal (4) is insulated (6). The canal is thermostatted at 37 °C by 4 peltiers (10), with their respective radiators (11) and fans (12). The rotor shaft is connected to a pulley (14) which transmits the motor movement (15) through a belt (17) and a pinion (16). The encoder disk (13) is attached to the pulley. The photosensors (18) relays the movement of the encoder to the electronic board. The washing operation has 10 cycles. In each cycle two tips are used. The longest is used for suctioning and the shortest for dispensing. • Cycle 1(26): The reaction mixture is suctioned and the washing solution is dispensed. The suctioned waste is sent directly to the high contamination waste bottle. • Cycle 2(27): The washing solution is suctioned and then dispensed again. • Cycle 3: Wait cycle during which the wells are washed • Cycle 4 to 6 (28): Rinsing, suctioning of liquid and dispensing of distilled water • Cycle 7: Wait cycle • Cycle 8: Optical checking of well • Cycle 9(29): Suctioning of distilled water • Cycle 10(30): Drying of well. During the last two cycles, in the event of the tips colliding with the rotor, a sensor (21) detects this and stops the operation. The whole tip assembly is secured mechanically with a bolt (22). The wash station has a built-in system for blocking the entry of light through the cover vents, part (25). This part is always in a lower position, touching the cover. When the wash station is raised and lowered, part (25) is maintained in its position, making contact with the cover, by means of guide elements (23) and springs (24). The wash station tip assembly is joined to a shaft (31). This shaft is dragged by a belt (37) through part (34). In turn, the motor (38) transmits the movement to the belt (37) through the pulley (39). The transmission pulley is protected by part (40). The tab (35) and photosensors (36) are used to detect the wash station start-up position.
Page 24 Service Manual Figure 3.9 Wash station tip assembly Figure 3.10 Wash station elevation system References of figures 3.9 and 3.10: 30 – Drying 20 – Wash station housing 31 – Wash station elevation shaft 21 – Tip collision sensor 32 – Wash station shaft anchoring support 22 – Set screw 33 – Counter pulley 23 – Pedal guide shaft 34 – Part anchoring shaft with belt 24 – Spring 35 – Start-up detection tab 25 – Pedal 36 – Start-up detection photosensor 26 – Waste aspiration 37 – Belt 27 – Washing solution aspiration 38 – Wash station motor 28 – Rinsing with water 39 – Transmission pulley 29 – Water aspiration 40 – Transmission pulley protector...
Page 25 Figure 3.11 Optical bench view Figure 3.12 Optical bench view References of figures 3.11 and 3.12 49 – Beamsplitters for each wavelength 41 – Optical bench 50 – Lenses and lens holder 42 – CIIM00051 board 51 – Rotor 43 – Cover sensor 52 – Optical bench support 44 – Temperature sensor 53 – Filters for each wavelength 45 – CIIM000050 board 54 – Filter holder 46 – Optical bench opening screws 55 – Leds for each wavelength 47 – Optical bench cover 56 – Principal and reference photosensors 48 – Optical bench seal The optical bench is secured directly to board CIIM00051 (42). The different leds (55) for each wavelength and the main and reference photodiodes (56) are welded to board CIIM00051 (42). The filters (53) for each wavelength are inserted in the filter holders (54) and screwed to the optical bench support (52). To ensure that the light beam for each wavelength hits the rotor (51) there are beam splitters (49) and lenses (50). The whole assembly is sealed by a rubber joint (48) and a cover (47).
Page 26 Service Manual 3.4. Pipetting arms The pipetting arms are used to suction and dispense fluids. There are three arms, two for handling reagents and one for handling samples. The pipetting arms are comprised of a housing (1) that covers the tip connections (6) and the electronic board (2). The tip and board assembly, attached to a support, is the mobile part of the arm. The assembly is raised by a guide tube (9) and the wires and tubes connected to the tip pass through this tube. The raising operation is executed with a motor (10) that transmits the movement through a pulley (11) to a belt joined to the guide tube (9). The angular movement is executed with the motor (4) by means of a belt (3) which makes the guide tube rotate (9). Figure 3.13 Pipetting arm assembly Figure 3.14 Reagent tip...
Page 27 References of figures 3.13 and 3.14 10 – Elevation movement motor 1 – Housing 11 – Elevation movement transmission pulley 2 – CIIM00049 board 12 – Tip thermostatting system cable 3 – Angular movement transmission belt 13 – Tip temperature sensors cable 4 – Angular movement motor 14 – Tip detection system cable 5 – Elevation movement initiation photosensor 15 – Collision detection photodiode 6 – Aspiration and dispensation tip 16 – Tip collision detection system 7 – CIIM00048 board 17 – Angular movement initiation photodiode 8 – Elevation movement transmission belt 9 – Elevation movement guide tube The only difference between the reagent and sample arms is the tip (6). Characteristics of the reagent tip and the sample tip: Reagent tip Sample tip Inner diameter at the end 0.8 mm 0.4 mm Maximum volume contained 500 mL 40 mL inside Thermostatted Temperature sensor Fluid detection The tip control board CIIM00049 (2) is the same for the reagent arm and the sample arm. 3.5. Stirring arm The elevation and rotation movement assembly part is the same as the pipetting arm assembly. See section 3.4 for a detail of the assembly. The stirrer is formed by a flat blade(5). The blade is inserted into the continuous current motor shaft (1) and pressed by a clamping nut (4). The motor (1) is attached to the head piece support (3) by an adapter (2). Figure 3.15 Stirrer arm head References of figure 3.15...
Page 28 Service Manual 3.6. Dispensing assembly The dispensing pump assembly is comprised of three pumps. Each pump is independent and they are connected to the reagent and sample arm tips. The pistons of the two pumps for pipetting the reagent have a diameter of 8 mm, while the piston of the sample pump has a diameter of 3 mm. The fluidic system of the three pumps with the input electro valves is comprised of a PMMA manifold (1). In the fluidic chamber of the sample pump the manifold has a pressure sensors that detects whether the sample tip is blocked (3). All three pumps are identical, except for the sample pump, in which the piston has a smaller diameter. They are operated by a motor (13) attached to a multi-twisting spindle (12). The spindle raises or lowers the piston support (11) where it is attached to the piston. The suctioning chamber is sealed by a retaining element (10). The tubes are connected to the manifold by connection fittings (7). Figure 3.16 Dispensation pump assembly Figure 3.17 Detail of dispensation pumps...
Page 29 References of figures 3.16 and 3.17 8 – 3 mm sample piston 1 – Manifold with electro valves 9 – 8 mm reagent piston 2 – Board with led lamp 10 – Retaining element 3 – Pressure sensor 11 – Piston support 4 – Sample pump 12 – Pump spindle 5 – Reagent 1 pump 13 – Pump motor 6 – Reagent 2 pump 7 – Output connection fitting 3.7. Structure Each of the analyser's subassemblies is attached to the structure (1). The sample rotor, reagent rotor, reaction rotor, sample arm, reagent arm and stirring arm subsassemblies are attached at the top. The pump and fluidic subassemblies are attached at the bottonm right-hand side. The electronics and power supplies are located on the top left-hand side. The ISE module (2) is located in the centre, at the top, and the ISE module reagent kit (6) is located in the bottom central part. See Figure 3.18. The washing solution bottles (5) and high contamination waste bottles (4) are located in the bottom central part. The volume in the bottles is determining by weighing. Below each bottle is a weighing scale (7). The general fans (12), (13) are fastened directly to the structure. The fan (3) is attached to the front panel. The wash stations for each tip and stirrer (10) are attached directly to the structure. The evacuation tubes are con- nected directly to the low contamination waste bottle. The distilled water bottles (14) and low contamination waste bottles (15) can be accessed from the rear bottom part. Double buoy sensors are used to detect the maximum and minimum levels of each container. The main switch is located at the bottom right-hand side (16), and the partial switches at the side (11). The external fluidic connections are located at the bottom left-hand side (17). Figure 3.18 Front view of structure...
Page 30 Service Manual Figure 3.19 Rear view of structure References of figures 3.18 and 3.19 10 – Wash station for tips 1 – Structure 11 – Lateral switches 2 – ISE module (optional) 12 – General fans 3 – Fridge fans 13 – Electronic compartment fans 4 – High contamination waste bottle 14 – Distilled water bottle 5 – Washing solution bottle 15 – Low contamination waste bottle 6 – ISE module calibration standards kit 16 – Main switch 7 – Bottle weighing scales 17 – External fluid connections 8 – Wheel 9 – Anchoring leg 3.8. Fluid connections The entire fluidic system is mounted on a board located on the right-hand side of the analyser. To facilitate the identification and monitoring of the fluidic system, the tube colour selection uses the following criterion: • Blue: Distilled water tubes • Red: Waste tubes • Green: Washing solution tubes...
Page 31 Figure 3.20 Fluidic system assembly References of figure 3.20 13 – SF1-EV2 electro valve 1 – SF1 board - fluidic system control 14 – SF1-B4 pump 2 – JE1 board - syringe control 15 – SF1-B5 pump 3 – Wash station tube heater 16 – Manifold 4 – SF1-B10 pump 17 – SF1-GE1 electro valve 5 – SF1-B3 pump 18 – Wash station pump 6 – SF1-B2 pump 19 – Wash station motor 7 – SF1-B1 pump 20 – JE1-EV4 electro valve 8 – SF1-B9 pump 21 – JE1-EV5 electro valve 9 – SF1-B8 pump 22 – JE1-B1 pump 10 – SF1-B7 pump 23 – JE1-B2 pump 11 – SF1-B6 pump 24 – JE1-B3 pump 12 – SF1-EV1 electro valve The water can enter the analyser in two ways: • Through a pressurised water system • Through an external tank with a large capacity The user programme will select the water entry method. In the first case, the programme will activate the electro valve (12) and fill the intermediate distilled water tank. In the second case the programme will activate the electro valve (13) and the pump (14), to suction water from the external tank.
Page 32 Service Manual The internal distilled water tank level is controlled by a buoy system. There is also an internal low contamination waste tank. The tank level is also controlled by a buoy system. When the system detects that the tank is full, the programme activates the pump (15) and evacuates the water externally. Pipetting system Each of the tips, sample, reagent 1 and reagent 2, is connected directly to its respective ceramic pump in the mani- fold assembly. When the pumps are suctioning or dispensing the samples or reagents, electro valves JE1-EV1, JE1-EV2 and JE1- EV3 will be closed. During the internal tip washing process, these electro valves will be open and can dispense distilled water, washing solution or air, depending on the selection made in the pre-manifold. The pre-manifold selects water, washing solution or air, depending on the state of the electro valves (20) and (21). Using the pumps (22), (23) and (24) it pumps the liquids selected by the sample, reagent 1 and reagent 2 tips, respectively. The outsides of the tips are also washed in the wash stations. Distilled water is used for washing the insides, and it is pumped to the sample tip by pump (7), to the reagent 1 and stirring 2 tips by pump (6) and to the reagent 2 and stirrer 1 tip by pump (5). Wash station The rotor washing system is comprised of 10 cycles. ) See chapter 2.5 for a description of each wash station cycle. Dispensing from each tip is executed with a pump that activates 5 pistons. The pump is operated by the motor (19). Each piston is connected to an electro valve (17) where the 2 first tips dispense washing solution and the other 3, distilled water. The tip of the first cycle suctions the high contamination waste through pump (4) and dispenses it directly into the bottle provided for that purpose. The tips of cycles 2 and 4 are suctioned by the same pump (11) and the suctioned material is evacuated into the low contamination waste tank. The tips of cycles 5 and 6 are suctioned by pump (10) and also emptied into the low contamination waste tank. The tip of cycle 9 is suctioned by pump (9) and the tip of cycle 10 executes the drying operation through pump (8). The last two pumps evacuate the suctioned material into the low contamination water tank.
Page 33 Service Manual 4. Electronic elements The electronics controlling the analyser are laid out in 14 independent boards. Each board controls an analyser sub- assembly. The method for transmitting the information between the boards is through a CAN communication bus. There are 2 more boards which are used to make the CAN bus interconnection. Some boards perform the same function and are repeated, for instance the boards that control the arms. To enable the information to be communicated through the bus and reach the correct board, the board must have a single identifier inside the analyser. For this reason each board has a series of switches so that the board identifier can be selected. The code assigned to each board is indicated below: Type of board Description of board Identification code Selector position Arm boards Sample 1 arm 0000 Reagent 1 arm 1000 Reagent 2 arm 0100 Stirrer 1 arm 0010 Stirrer 2 arm 1010 Detection boards Sample 1 detection 0110 Reagent 1 detection 1110 Reagent 2 detection 0001 Rotor boards Sample 1 rotor 0101 Reagent 1 rotor 0011...
Page 34 Type of board Description of board Identification code Selector position Fluidic system Fluidic system 1111 board Syringe board Syringes 0100 Each of the above boards has a microprocessor. To rapidly identify the microprocessor status, they have a built-in state indicator led. The information provided by the flashing of the led is the following: Status Description Rapid flashing (burst) Board start-up. After a few seconds, the flashing changes to slow. Rapid flashing Board in monitor mode. Slow flashing Board has firmware and is operating correctly. Very rapid flashing. With Firmware update process. no regular sequence Not flashing Board not supplied with power or damaged. The analyser chassis, and all its metallic parts are only connected to the socket ground wire. This is the electrical safety wire. The negative reference or of the electrical circuit is isolated from the chassis. To measure the voltages with a multimeter or an oscillocope, place the instrument reference at the “test points” NOTE marked in each board or the CAN connector reference connection Figure 4.21 Sources and input-AC board - CIIM00056 Figure 4.1 Silkscreen printing of input-AC board...
Page 35 Service Manual FN 284-10-06 UNIVERSAL INPUT PLMA00258 94V - 264V 600W CIIM00056 AC INPUT FRIDGE PS MAIN PS FRIDGE PS MAIN PS FRIDGE MAIN SP-320-24 SP-320-24 RS-35-24 24V 13A 24V 13A 24V 1.5A FA FRIDGE FA SF1 FA ISE FA MAIN FA MAIN Figure 4.2 Power supply input connection diagram.
Page 36 Figure 4.3 Distribution board silk printing Connector Function CN1 A Connection to the CPU board CN1 B CN2 A Connection to the JE1 board CN2 B Connection to the GLF board CN3 A Connection to the SF1 board CN3 B Connection to the AG1 board CN4 A Connection to the DM1 board CN4 B Connection to the AG2 board CN5 A Connection to the DR2 board CN5 B Connection to the BR1 board CN6 A Connection to the DR1 board CN6 B Connection to the BM1 board CN7 A Connection to the RR1 board CN7 B Connection to the BR2 board CN8 A Connection to the RM1 board CN8 B Interconnection of distribution boards, only for the CAN CN20 Connection to the power source LEDs...
Page 37 Service Manual If it should be necessary to remove a CAN cable, take the following steps (see Figure 4.4): Figure 4.4 Disconnecting a CAN connector 1. Press the sides of the connector firmly (1). There are tabs on each side for insertion into the female connector. 2. Pull the connector and cable outward (2). 3. Do not pull the cable directly. 4. If you cannot remove the cable, use a pair of flat tip pliers that are wide enough to push the tabs. All the CAN cables have three labels placed at their ends. • One label indicates to which board it is connected and the board identifier, and is used to distinguish the cables by their lengths, given that in terms of their construction, all the cables are identical. • The other two labels are at both ends of the cable, one is yellow and the other is white. The end with the yellow marks is the one that must be connected to the distribution board. Figure 4.5 Itemised description of the CAN connector Figure 4.5 shows a CAN connector with the pins (1), connector (2) and extra anchoring (3). Steps for mounting a CAN connector:...
Page 38 1. Place each of the pins (1) so that they compress the cable in the connector compartment (2). The pins have a single position. 2. Insert the pins as far as they will go. The pins must be anchored. 3. Insert through the side of the connector (2) the extra anchoring (3) until it clicks into place. 4.2. Main board (CPU) - CIIM00046 This is the main board in which the tasks are distributed (in terms of the firmware) to each of the subassembly boards. This board also controls the following devices: • The computer communications through RS-232 and USB • The analyser status lamp • The analyser main cover sensor. • The general fans of the analyser. These fans have two wires. • Control in sending the commands for controlling the ISE module and receiving the results thereof. The electronic control system for the RS-232 for communications and for the ISE module is electrically isolated from the main electronic system. To supply it with power, use a special insulated regulator (U20 and U3). USB supplied by the computer and insulated from the equipment electronic system. Figure 4.6 CPU board silk printing...
Page 39 Service Manual CIIM00046 PLMA00286 STATUS LED BICOLOUR CAN BUS LED STATUS LED STATUS CON3 CON3 CAN BUS RS-232 RS-232 RS-232 RS-232 -ISE MODULE RS-232 -ISE MODULE CN10 CN21 CN21 F.FAN1 CPU F. FAN1 CN20 CN20 CN21 CN21 PLMA00285 DETECTOR COVER COVER SENSOR COVER SENSOR Figure 4.7 CPU board connections...
Page 40 Connector Function CN19 General fan Pin 1: 24 V Pin 2: Activation CN20 General fan Pin 1: 24 V Pin 2: Activation CN21 General fan Pin 1: 24 V Pin 2: Activation Test point Function GND ISE TP18 ISE transmission serial channel TP19 ISE reception serial channel TP26 GND serial channel TP27 Transmission serial channel TP28 Reception serial channel TP29 USB + signal TP31 USB - signal TP33 USB transmission serial channel TP34 USB reception serial channel TP38 3.3 V TP40 24 V TP41 TP42 CAN_H (bus signal) TP43...
Page 41 Service Manual 4.3. Arm boards - CIIM00048 These boards are located on each of the five arms. The board has a micro controller (U1) which controls the drivers of the motors that move the arm vertically (U7) and horizontally (U8). It also contains the electronic control system of the start-up sensors for each motor. CIIM00048 PLMA00324 HORIZONTAL DETECTOR CN14 CN14 MOTOR H CN16 CN16 MOTOR H CAN BUS CON3 CON3 CN10 CN10 PLMA00323 HORIZONTAL MOTOR HOME H HOME H CN15 CN15 HOME V CON3 CON3 PLMA00325...
Page 42 Connector Function CN16 CAN bus connection Pin 1: 24V Pin 2: GND Pin 3: NC Pin 4: CAN_H Pin 5: CAN_L Vertical motor Pin 1: Coil 1 Pin 2: Coil 1 Pin 3: Coil 2 Pin 4: Coil 2 CN10 Horizontal motor Pin 1: Coil 1 Pin 2: Coil 1 Pin 3: Coil 2 Pin 4: Coil 2 CN14 Horizontal start-up detection Pin 1: Detection Pin 2: GND Pin 3: 5V CN15 Vertical start-up detection Pin 1: Detection Pin 2: GND Pin 3: 5V Test point Function Horizontal motor reference voltage Horizontal stepper motor Vertical motor reference voltage Board selection. Direction 1 24 V Board selection. Direction 2 3.3 V Vertical stepper motor TP10 Board selection. Direction 3 TP11...
Page 43 Service Manual 4.4. Tip detection board - CIIM00049 Board located in the upper part of the sample and reagent arms. These boards control the following elements, through a micro controller (U10): • Fluid detection system • Tip collision sensor • The heating element and temperature sensor only in the reagent tips. • Protection against ESD in the tip. CIIM00049 PLMA00330 PROBE +tº +tº TEMPERATURE SENSOR CON2...
Page 44 Figure 4.11 Tip board silk printing Connector Function CAN bus connection Pin 1: 24V Pin 2: GND Pin 3: NC Pin 4: CAN_H Pin 5: CAN_L Tip temperature sensor Pin 1: 3.3 V Pin 2: Sensor Tip resistance Pin 1: Resistance Pin 2: Resistance Detection of tip Pin 1: Detection signal Pin 2: Injection signal Test point Function Board selection. Direction 1 Board selection. Direction 2 Board selection. Direction 3 Board selection. Direction 4 3.3 V TP19 Tip collision detection...
Page 45 Service Manual LEDs Function (on condition) CPU status Collision detection Sample detection status 4.4.1. Level detection adjustment Material required to make the adjustment: • plastic, flat-tip precision screwdriver. Bourns or similar trimming tool. A plastic screwdriver must be used, to prevent perturbations in the detection signal while the power meter turns. Do not use a metal screwdrive as it will affect the signal. The state of led LD3 indicates the detection frequency adjustment. The process must be made when the analyser is on stand-by and the tip is correctly primed. If the led flashes or if off, this indicates that the detection frequence is not adjusted. As the adjustment frequency is approached, the led will flash more rapidly until it remains on when the target detection frequency is reached. The detection frequency for the sample tip is: 2M Hz The detection frequency for the reagent tip is: 1M Hz Steps for making the adjustment: 1. Turn on the analyser 2. Remove the cap from the tip you want to adjust 3. Insert the plastic screwdriver into the power meter (P1). Ensure that the tip is correctly primed and not touch- ing any fluid. 4. Gently turn the power meter in the direction in which the LD3 led flashing frequency increases until it stops flashing. 5. If the frequency falls, change the direction for turning the power meter. Potential problems in the tip detection adjustment: Detection problem Solution It is impossible to achieve the stable Check that the cable protective mesh is correctly compress on the flashing of the LD3 adjustment led connector pin. Check that the cable is not pinched.
Page 46 4.5. Photometric control board- CIIM00050 Board located in the reading rotor. It contains a micro controller (U5) which controls the following elements: • Reaction rotor cover detection (U7) • Wash station motor (U14) • Wash station start-up detection (U10) • Wash station collision detection (U10) • Photometric board connection • Reaction rotor motor (U12) • Reaction rotor start-up detection (U10) • Reaction rotor encoder detection (13) • Peltier control in thermostatting the reaction rotor (U18) • Fan control for cooling the peltiers (U17). There are 3 fans with 3 wires. • Reaction rotor thermostatting temperature sensor control (U15 and U16) CIIM00050 ROTOR PLMA00321 DETECTOR CAN BUS HOME ROTOR GLF1 HOME ROTOR CAN BUS CON3 CON3 CIIM00051...
Page 47 Service Manual Figure 4.13 Photometric control board silk printing Connector Function CAN bus connection Pin 1: 24V Pin 2: GND Pin 3: NC Pin 4: CAN_H Pin 5: CAN_L Rotor cover detection Pin 1: 5V Pin 2: Cover detection Wash station collision detection Pin 1: GND Pin 2: Wash station detection Pin 3: GND Pin 4: Wash station collision Photometric board connection Rotor motor Pin 1: Coil 1 Pin 2: Coil 1 Pin 3: Coil 2 Pin 4: Coil 2 Rotor encoder Pin 1: GND Pin 2: C channel encoder Pin 3: A channel encoder Pin 4: 5 V Pin 5: B channel encoder...
Page 48 Connector Function Rotor start-up detection Pin 1: Detection Pin 2: GND Pin 3: 5V Wash station motor Pin 1: Coil 1 Pin 2: Coil 1 Pin 3: Coil 2 Pin 4: Coil 2 CN10 Wash station detection Pin 1: Detection Pin 2: GND Pin 3: 5V CN11 Tip temperature sensor Pin 1: 3.3 V Pin 2: Sensor CN12 Pin 1: 24 V Pin 2: Detection diagnostic Pin 3: Activation CN13 Pin 1: 24 V Pin 2: Detection diagnostic Pin 3: Activation CN14 Pin 1: 24 V Pin 2: Detection diagnostic Pin 3: Activation CN15 Pin 1: 24 V Pin 2: Detection diagnostic Pin 3: Activation CN16 Peltier Pin 2: Peltier activation Pin 3: Peltier activation CN17 Peltier Pin 2: Peltier activation...
Page 49 Service Manual Test point Function TP41 Motor driver step voltage TP51 Rotor temperature LEDs Function (on condition) 3.3 V activation CPU start-up Wash station rest phase detection Rotor start-up detection Wash station start-up detection 4.6. Photometric readings board - CIIM00051 This board is located below the optical bench in the reaction rotor assembly. The board has the leds for each wave- length and the two photosensors directly welded to it. This board controls the switching on and off of each led. The leds are controlled through a power source (U2, U8, U9 and T13) and the led on selection is done through a decoder (U11). The readings are made through two photodiodes (main and reference photodiodes) which are read by a double integrating ramp converter (U1, U4, U5 and U6). All the control signals are sent to the photometric control board (CIIM00050) through an I2C channel (U7) Figure 4.14 Photometric control board silk printing Connector Function Photometric board connection Test point Function LED voltage LED voltage Decoder 1...
Page 50 Test point Function Decoder 2 Decoder 3 Decoder 4 TP10 Activation of LED 1 TP11 Activation of LED 2 TP12 Activation of LED 3 TP13 Activation of LED 4 TP14 Activation of LED 5 TP15 Activation of LED 6 TP16 Activation of LED 7 TP17 Activation of LED 8 TP18 Activation of LED 9 TP19 Activation of LED 10 TP20 Activation of LED 11 TP21 Activation of LED 12 LEDs Function (on condition) 340 nm LED 560 nm LED 670 nm LED 600 nm LED 535 nm LED 505 nm LED 635 nm LED 405 nm LED Free position LD10 Free position LD11...
Page 51 Service Manual • Rotor motor (U8) • Rotor start-up detection (U3) • Barcode reading communication (U3 and U4) Fridge components mounted on the reagent rotor board • Separate power supply (U16) • Micro controller (U13) • Reading window demisting driver (U10 and U17) • Thermistor for controlling fridge • Fridge peltier control (U9 and U11) • Fridge peltier fans (U9 and U11), controlled by the same drivers as the peltiers CIIM00052 B-PLMA00332 CIIM00052-A : REAGENT CN26 CN26 CIIM00052-B : SAMPLE A-PLMA00336 ROTOR DETECTOR CAN BUS CN11 CN11 ROTOR HOME ROTOR CAN BUS HOME...
Page 52 Figure 4.16 Rotor board silk printing Connector Function CAN bus connection Pin 1: 24V Pin 2: GND Pin 3: NC Pin 4: CAN_H Pin 5: CAN_L Separate fridge power supply Pin 1: 24 V Fridge Pin 2: GND Fridge Demister Pin 1: 24 V Pin 2: Activation Barcode reader Pin 1: Activation/deactivation Pin 2: Reading channel 1 Pin 3: Transmission1 Pin 4: GND Pin 6: Reading channel 2 Pin 9: Reading shot Pin 10: Transmission2 General fan Pin 1: 24 V Pin 2: GND...
Page 53 Service Manual Connector Function General fan Pin 1: 24 V Pin 2: GND Cover sensor Pin 1: 5V Pin 2: Detection signal Rotor motor Pin 1: Coil 1 Pin 2: Coil 1 Pin 3: Coil 2 Pin 4: Coil 2 CN11 Rotor start-up detection Pin 1: Detection Pin 2: GND Pin 3: 5V CN12 Peltier Pin 1: 24 V Pin 2: Peltier diagnostic Pin 3: Peltier diagnostic Pin 4: GND CN13 Peltier Pin 1: 24 V Pin 2: Peltier diagnostic Pin 3: Peltier diagnostic Pin 4: GND CN14 Fridge fan Pin 1: 24 V Pin 2: Detection diagnostic Pin 3: GND CN15 Fridge fan Pin 1: 24 V Pin 2: Detection diagnostic Pin 3: GND CN16...
Page 54 Test point Function TP11 24 V Fridge TP12 5 V Fridge TP13 CAN_L TP14 Board selection. Direction 4 TP15 Board selection. Direction 3 TP19 Rotor stepper motor LEDs Function (on condition) 3.3 V voltage 3.3 V voltage Fridge Barcode reader activation Microprocessor start-up Cover detection Rotor start-up detection Fridge peltier activation LD10 Fridge peltier activation LD12 Fridge microprocessor start-up 4.8. Fluid control board – CIIM00053 This board is located at the top of the fluid zone. The board controls the following elements, through a micro controller (U10): • Stirrer driver (U18) • Scales signal conditioning (U5 and U6) for the washing solution and high contamination waste • Internal water and waste bottle buoy conditioning • Driver for the wash station water heater (U1) • Temperature sensor for controlling the thermostatting of the wash station water • Wash station water dispensing driver...
Page 55 Service Manual CIIM00053 CAN BUS WASHING WPUMP STATION CAN BUS DETECTOR CN26 CN26 HOME ALTERNATIVE FA SF1 WPUMP SUPPLY SF1-B1 CN19 CN19 PUMP SF1-WPUMP WASHING STATION SF1-B2 CN20 CN20 CN26 CN26 MOTOR PUMP CN21 CN21 SF1-B3 SENSOR WATER PUMP WATER SENSOR SF1-B4 SENSOR WASTE PUMP...
Page 56 Connector Function Distilled water bottle level detection sensor Pin 1: GND Pin 2: Bottom sensor Pin 3: GND Pin 4: Top sensor High contamination waste bottle scales signal Pin 1: GND Pin 2: Signal 1 Pin 3: Signal 2 Pin 4: 3.3 V Wash station scales signal Pin 1: GND Pin 2: Signal 1 Pin 3: Signal 2 Pin 4: 3.3 V B4 pump Pin 1: 24 V Pin 2: Activation signal CN10 B7 pump Pin 1: 24 V Pin 2: Activation signal CN11 B6 pump Pin 1: 24 V Pin 2: Activation signal CN12 B5 pump Pin 1: 24 V Pin 2: Activation signal CN13 GE1 wash station dispensation electro valve Pin 1: 24 V assembly Pin 2: Activation signal Pin 3: 24 V Pin 4: Activation signal Pin 5: 24 V Pin 6: Activation signal Pin 7: 24 V Pin 8: Activation signal...
Page 57 Service Manual Connector Function CN22 E1 electro valve Pin 1: 24 V Pin 2: Activation signal CN23 E2 electro valve Pin 1: 24 V Pin 2: Activation signal CN24 E3 electro valve Pin 1: 24 V Pin 2: Activation signal CN26 Wash station water dispensation motor Pin 1: Coil 1 Pin 2: Coil 1 Pin 3: Coil 2 Pin 4: Coil 2 CN27 Wash station water dispensation start-up Pin 1: Detection detection Pin 2: GND Pin 3: 5V CN28 Wash station water thermostatting thermostat Pin 1: output 1 Pin 2: GND Figure 4.18 Fluid control board silk printing Test point Function 24 V (bus voltage) GND (bus voltage)
Page 58 Test point Function CAN_L (bus signal) Stirrer DC voltage 3.3 V TP11 Motor driver reference voltage TP12 Stepper motor TP13 Board selection. Direction 1 LEDs Function (on condition) 3.3 V voltage Heater activation Activation of pump 1 Activation of pump 2 Activation of pump 3 Activation of electro valve 1 Activation of electro valve 2 Activation of electro valve 3 Microprocessor start-up LD10 Motor start-up detection 4.9. Syringe control board - CIIM00054 This board is located at the top of the fluid zone. The board controls the following elements, through a micro controller (U1): • Sample circuit pressure sensor (clot sensor) • Manifold led power supply • Sample dispensation motor driver • Sample dispensation start-up sensor • Reagent 1 dispensation motor driver • Reagent 1 dispensation start-up sensor • Reagent 2 dispensation motor driver...
Page 59 Service Manual CIIM00054 CAN BUS REAGENT 1 HOME REAG1 PUMP CAN BUS DETECTOR CN19 CN19 CLOT SENSOR JE1 HOME CLOT DETECTOR REAG1 SENSOR REAGENT 1 CN18 CN18 EV1-JE1 REAG1 PUMP MOTOR REAG1 EV4-JE1 EV3-JE1 REAGENT 2 HOME REAG2 PUMP EV2-JE1 DETECTOR CN17 CN17...
Page 60 Connector Function Activation of electro valve EV3 Pin 1: 24 V Pin 2: Activation signal Activation of electro valve EV2 Pin 1: 24 V Pin 2: Activation signal CN10 Activation of pump GE1 Pin 1: 24 V Pin 2: Activation signal CN11 Activation of pump B3 Pin 1: 24 V Pin 2: Activation signal CN12 Activation of electro valve EV5 Pin 1: 24 V Pin 2: Activation signal CN13 Activation of electro valve GE3 Pin 1: 24 V Pin 2: Activation signal CN14 Activation of electro valve GE2 Pin 1: 24 V Pin 2: Activation signal CN15 Activation of electro valve EV6 Pin 1: 24 V Pin 2: Activation signal CN16 Reagent 2 dispensation motor Pin 1: Coil 1 Pin 2: Coil 1 Pin 3: Coil 2 Pin 4: Coil 2 CN17 Reagent 2 start-up detection Pin 1: Detection Pin 2: GND Pin 3: 5V...
Page 61 Service Manual Figure 4.20 Syrigne control board silk printing Test point Function Board selection. Direction 1 Board selection. Direction 2 Board selection. Direction 3 Board selection. Direction 4 24 V (bus voltage) GND (bus voltage) 24 V TP10 CAN_H (bus signal) TP12 CAN_L (bus signal) TP13 3.3 V TP14 Reagent 2 motor reference voltage TP15 Reagent 2 stepper motor driver voltage TP16 Reagent 2 motor reference voltage TP17 Reagent 2 stepper motor driver voltage TP18 Sample motor reference voltage TP19 Sample stepper motor driver voltage...
Page 62 LEDs Function (on condition) Microprocessor start-up 3.3 V voltage Activation of pump 1 Activation of pump 2 Activation of electro valve 1 Activation of electro valve 2 Activation of electro valve 3 Activation of electro valve 4 Activation of pump 1 LD10 Activation of pump 2 LD11 Activation of electro valve 1 LD12 Activation of electro valve 2 LD13 Activation of electro valve 3 LD14 Activation of electro valve 4 LD15 Reagent 2 motor start-up detection LD16 Reagent 1 motor start-up detection LD17 Sample motor start-up detection 4.10. Loading of firmware The firmware loading process is executed through the service programme. See chapter 8.6.8 Updating firmware. A single file will be distributed, containing the individual firmware for each board. The process consists of first sending the file to the main board (CPU) which stores it in a flash drive or repository. Once it has been verified that the file sent is correct, the service programme will ask the user to confirm the start of the CPU board firmware updating process. Once the CPU board has been updated, it checks the compatibility of the versions of each of the boards against those in the repository. If any board has a version that is not compatible with the one in the reposi- tory, it updates the firmware of that board. While the firmware file is transmitted with the service programme, the analyser status led will flash and change colour. All the analyser adjustments are stored in the CPU board memory. When the analyser is initialised, the necessary adjustments for each board are sent.
Page 63 Service Manual 5. Fluidic elements The analyser operates with 4 tanks for processing fluids. These tanks are: the distilled water tank, low contamination waste tank, washing solution tank and high contamination waste tank. The distilled water and low contamination waste tanks are located at the bottom rear part of the analyser, and can only be accessed by the technical service. Full and empty level control is executed through a double-buoy system. The washing solution and high contamination waste tanks are located at the front bottom part of the analyser. They can be accessed directly by the user. • Once the determination has been made, the reagent and sample mixtures are sent to the high contamination waste tank. The tank has a capacity of 5 L and autonomous operation of at least 20 h. • The tank that contains washing solution has a capacity of 5 L and autonomous operation of at least 8 h. The washing solution is used in the wash station to clean the reaction rotor and during the analyser initialisation and finalisation processes. • All the waste from the reaction rotor wash station is deposited in the low contamination waste tank, in addition to the waste from the tip and stirrer wash stations. The tank has a capacity of 5 L and automatically empties the content outside the apppliance through a buoy control process. The system uses the SF1-B5 pump to empty the tank. • The internal distilled water tank has a capacity of 5 L. The water is used to prime the pipetting system, wash the inside and outside of the sample and reagent tips and wash the reaction rotor. The tank has two water inlets that are selected by the software. One inlet is from an external tank. For this purpose the analyser uses the SF1-EV2 and the SF1-B4 pump. The other inlet is through a water mains connection. When the water mains connection is selected, in the event that there is pressure, only one SF1-EV1 electro valve is used. The analyser fluidic diagram is shown below.
Page 64 Figure 5.1 Fluidic diagram...
Page 65 Service Manual Figure 5.2 Enlarged view of the fluidic diagram...
Page 66 Service Manual 6. Service programme The service programme enables the analyser to be adjusted and checked, and is also used to locate failures in the analyser. 6.1. Identification of the programme parts. The programme screen has two parts which are common to all the menus. See Figure 6.1 1 – Menu bar 4 – Adjustment panel 2 – Help panel 5 – Status icons 3 – Lateral bar 6 – Message lines Figure 6.3 Screen format Name Description Menu bar This gives access to the programme menus. Help panel An incrusted help screen indicates the adjustment process for each type of adjustment on a step-by-step basis. Lateral bar Analyser operation icons. Adjustment panel Panel with different options for adjusting the positioning. Status icons Icons that permanently indicate the status of certain elements in the analyser. Message line Status line indicating messages for executing actions. The messages are shown in 2 locations.
Page 67 6.1.1. List of common icons The following chart shows the meanings of the common icons: Icon Name Description Edit Enables values to be edited. Delete Eliminates an element. Adjustment Initiates the adjustment process. Save Saves the adjustment made Undo Undoes and recovers the last adjustment. Close Closes the window. Accept Accepts the changes and closes the window. Print Launches a print request. 6.1.2. Vertical bar icons list The vertical bar icons list shows the icons that perform actions directly on the analyser. The following chart contains a decription of each one. Icon Name Description Stop This icon is used to immediately stop an execution in course. Connect This icon is used for connecting the programme with the analyser. Shut down This icon is used to stop and shut down the analyser.
Page 68 Service Manual Element Name Description Range Permitted range Indicates the permitted range of the units displayed. Steps Units Indicates the magnitude units. They are usually steps. Initial position Moves the mechanical element to its initial position. Unit increments Makes the increments one by one Increments by Makes the increments by tens tens x100 Increments by Makes the increments by hundreds hundreds Left steps Executes a mechanical movement to the left, one, ten or one hundred steps, depending on the above selection. Right steps Executes a mechanical movement to the right, one, ten or one hundred steps, depending on the above selection. Upward steps Executes a mechanical movement upward, one, ten or one hundred steps, depending on the above selection. Downward steps Executes a mechanical movement downward, one, ten or one hundred steps, depending on the above selection. Accept value Executes an absolute movement. A numerical value can be entered directly in the box and then the movement is excuted by pressing this button. 6.1.4. Description of the status icons Information about the analyser appears constantly at the bottom of the screen. See Figure 6.2 Figure 6.4 Status icons The following chart shows the meaning of each element:...
Page 69 Element Description Sample cover Indicates the status of the sample cover Reaction cover Indicates the status of the reaction cover Connected Indicates the status of the analyser connection with the programme 6.2. Programme initialisation To start up the programme, double click on the icon located on the desktop: or execute the programme from the following route: Start/All Programmes/Biosystems/BA400 Service When the programme is started a welcome screen is displayed and then the screen for identifying the user, as shown in Figure 6.3 Figure 6.5 Home screen Enter the username and password to access the programme. Field Value Username SERVICE Password BA400 6.3. Description of the menus The following chart shows the content of each programme menu Menu Name Description Setup It gives acccess to the different programme setup options • General • Language • Barcode...
Page 70 Service Manual Menu Name Description Adjustments/Test Gives access to the different options for adjusting and checking the different analyser subassemblies • Positioning • Photometry • Bottle level • Motors, valves and pumps • Thermostatting • Level detection • Barcode • ISE module • Clot sensor • Stress mode Utilities Gives access to the utilities assembly: • Conditioning • Demo mode • Analyser information • Hardware versions • Updating of firmware Recording and Gives access to the report options maintenance • Historical reports...
Page 71 • Reagent rotor cover • Clot sensor Figure 6.6 Analyser setup screen 6.4.2. Communications Enables the configuration of the communication channel between the service programme and the analyser. Select one of the following options: Automatic: Select this option and the programme will automatically search for the computer output port for communicating with the analyser. Manual: Select this option for the port to be selected manually. Type of connection: In the manual mode, select the type of connection you want • RS-232 — you should normally select the COM1 port • USB — you should normally select the USB1 port Press the button to ensure that the communications are functioning properly. Figure 6.7 Communication setup screen...
Page 72 Service Manual 6.4.3. Language This allows you to change the application language. There are two languages: Spanish and English. 6.4.4. Barcode This enables the barcode readers to be activated/deactivated and the barcode options to be configured. Figure 6.8 Barcode reader setup screen Deactivation of barcode for reagents: • Check this option to deactivate the barcode reader of the reagent rotor. Deactivation of barcode for samples: • Check this option to deactivate the barcode reader of the sample rotor. Type: • Select the barcode type used for printing the labels on the sample tubes. Total barcode size: • Selet the total size of the barcode for the sample reader. The reader will only read the codes of the indicated size, otherwise, it will mark the reading as a code error. External ID: • If the barcode has more information than the patient identifier, select the start and end of the patient identifier.
Page 73 Figure 6.9 User creation screen. 6.5. Adjustments/Test 6.5.1. Adjust positioning This menu is used to access the screens for adjusting the positions of the different mechanical elements of the ana- lyser, such as arms, rotors, etc To adjust some elements, a mechanical adjustment must be made as well as an adjustment in the service programme. 6.5.1.1. Optical centring adjustment This adjustment is used to centre each well in the reading rotor with respect to the optical system light beam. The firing point used to make the reading is also adjusted with respect to the centering of the rotor. The screen displays the reading profile of 5 wells. The adjustment box is used to position the vertical lines in the centre of the wells. To do this, move the rotor step by step until the reading tip is in the centre of the wells. If a reading is saturated or has insufficient light, move the sliding led current device to increase or decrease the luminous intensity of the reading led. 1. Press the adjustment start button. The programme will make the optical reading of 5 wells in the rotor. 2. Step by step, move the encoder firing point with the adjustment box until the indicator line (4) is correctly centred with respect to the well. 3. Save this position. 4. Bear in mind that if this value is changed, all the other mechanical elements will have to be adjusted.
Page 74 Service Manual 1 – Encoder steps 3 – Rotor optical reading 2 – Encoder reading 4 – Encoder firing adjustment Figure 6.10 Wash station adjustment screen. 6.5.1.2. Wash station adjustment This function is used to adjust the height of the wash station. The wash station centring must be manually adjusted beforehand. Manual adjustment of the wash station positioning: The manual adjustment process has two separate movements; vertical and horizontal. Each one is set using different screws. Figure 6.11 Wash station adjustment 1. Loosen the screw (1) anchoring the wash station in the vertical direction. 2. Move the wash station head until the tips are not touching the sides of the rotor. 3. Tighten the screw (1). 4. Loosen the screw (2) anchoring the wash station in the horizontal direction.
Page 75 5. Move the wash station head until the tips of the station are properly centred with the rotor. 6. Tighten the screws (2). After making the mechanical adjustment, adjust the height of the wash station with the service programme. See Figure 6.10. Figure 6.12 Wash station position adjustment screen 1. Press the adjustment start button. 2. Move the vertical positioning of the wash station using the adjustment box. 3. Step by step, move the wash station to lower the station tips until the tip of the dryer touches the rotor and the spring is lightly pressed (about 0.5 mm). 4. Save the positioning value. 6.5.1.3. Adjusting the arm positioning In this screen (Figure 6.11) you can adjust the vertical positioning, height and positioning in the rotor of all five arms: sample, reagent 1, reagent 2 and stirring arms 1 and 2. The screen shows a tab for each type of arm (1). Figure 6.13 Screen for adjusting the arm positioning...
Page 76 Service Manual Each tab contains a table with the positions that can be adjusted for each arm (2). Depending on each position, the necessary adjustment boxes (4) will be activated for moving the selected element step by step. With respect to the 3 possible values to be changed in each position: vertical, Z and rotor, not all can be memorised as adjustments. Some can be changed to facilitate the adjustment, but not memorised. The top of the table is marked in yellow, to indicate which parameters are adjustments and are memorised. After making and saving the adjustments, an OK tick will appear at the side of the element and then the next ele- ment is automatically accessed. It is also possible to verify the positioning of each mechanical element in this screen. To do this, press the Checkbut- ton (3). The selected element will be moved to the adjusted position. Then the different positions that can be adjusted, depending on the arm, are displayed. Sample arm Adjustment position Description Dispensation Adjustment of the dispensation point in the reagent rotor Predilution Adjustment of the dispensation point in the reagent rotor predilution well Z Ref. Adjustment of the reference position for lowering the tip in the reaction rotor. To facilitate the adjustment, the reference is the rotor surface. See Figure 6.12 Washing Adjusting the position of the tip in the wash station. Ring 1 Adjusting the position of the arm in ring 1 of the sample rotor. The vertical angle of the arm, arm depth and rotor angle are adjusted. The depth is adjusted for each sample well. Ring 2 Adjusting the position of the arm in ring 2 of the sample rotor. The vertical angle of the arm, arm depth and rotor angle are adjusted. The depth is adjusted for each sample well. Ring 3 Adjusting the position of the arm in ring 3 of the sample rotor. The vertical angle of the arm, arm depth and rotor angle are adjusted. The depth is adjusted for each sample well. Z tube Adjusting the depth of the tubes. This adjustment is used for the 3 rotor rings. ISE position Adjusting of the dispensation tip when the sample enters the ISE module.
Page 77 Reagent 1 and 2 arms Adjustment position Description Dispensation Adjustment of the stirring point in the reaction rotor Z Ref. Adjustment of the reference position for lowering the tip in the reaction rotor. To facilitate the adjustment, the reference is the rotor surface. See Figure 6.12 Washing Adjusting the position of the stirrer in the wash station. Parking Adjustment of the arm parking positioning. Icon appearing when stirring arms 1 and 2 are selected. When it is pressed the stirring rotation is activated and deactivated. In this way, it can be verified whether the stirrer is touching the rotor while in operation. Figure 6.14 Z ref. adjustment point 6.5.2. Photometry This menu is used to verify the led currents and for photometric verifications. The currents are adjusted every time a baseline is performed 6.5.2.1. Baseline and darkness current This screen is used to adjust the currents for each led. See Figure 6.13. To make the adjustment, a well must be filled with distilled water. The well can be filled automatically by the ana- lyser or manually by the user. 1. To do this, select the desired option (1) and choose the number of the well to be filled. 2. Press the icon for raising or lowering the wash station in order to remove or insert a rotor. 3. Press the adjust button to start the current adjustment process for each led. This is an automatic process that changes the led current, using both photodiodes (main and reference) to make the reading. The objective is to ensure that the number of counts of the photodiode with the most light succeed is close to 900,000 without the other photodiode becoming saturated.
Page 78 Service Manual 5. A bar chart is shown in position (3) of the screen with the numerical values of the results for the number of counts obtained for the main photodiode and the reference photodiode. 6. All values outside the pre-established ranges will be marked with a warning symbol. 7. The darkness current values for the main and reference photodiodes are shown in position (4) of the screen. The darkness current is the current ready by the photodiode when there is no light. Figure 6.15 Current adjustment screen 8. Press the edit button to access the screen for memorising the reference currents. See Figure 6.14. 9. The reference currents are current values memorised initially and they are used for comparison with the values obtained in each baseline. This way, the changes in luminious intensity for each led can be determined. This comparison process is automatic and the user is only warned if the compared values are widely diverging. 10. Due to the long life of the leds and the “Hard Coating” filters, a warning is given only in the event of a failure. If a led or filter is damaged. 11. In the event of a failure, meaning that a filter or led must be replaced, the technician must memorise the refer- ence current again. 12. Select the wavelength on which the operation was performed and press save. Figure 6.16 Screen for memorising the reference currents.
Page 79 6.5.2.2. Metrology This option is used to check the analyser photometry status. See Figure 6.15. The following checks can be made: • Repeatabilty of the readings. • Stabiliity of the readings. • Absorbance reading. Figure 6.17 Photometric verification screen. To make a verification the rotor must be filled with distilled water. This can be performed by the analyser or the user can do it manually. 1. Select the rotor filling mode and the well where the readings will be made 2. Press the icon for raising or lowering the wash station in order to remove or insert a rotor. 3. If you want to measure the absorbance of a specific reagent or fluid, select the manuall filling option. Dispense the fluid to be measured into a well. In the screen, select the well where the fluid was dispensed. 4. Select the type of measurement to be made. 5. Press the adjustment button to start the measuring process. Repeatability This verification takes measurements in all the wavelengths for 3 minutes. It is used to verify the repeatability of the photometric system readings After taking the measurements it shows the following parameters for each wavelength: • Mean • Standard deviation of all measurements • Coefficient of variation (CV) • Maximim absorbance • Minimum absorbance See chapter AIII ranges accepted for parameters.
Page 80 Service Manual Stability This verification takes measurements in all the wavelengths for 30 minutes. It is used to verify the stability of the photometric readings After taking the measurements it shows the following parameters for each wavelength: • Mean • Standard deviation of all measurements • Coefficient of variation • Maximim absorbance • Minimum absorbance Absorbance reading This allows you to measure the aborbance of a selected well. 6.5.3. Scales, bottles and tanks 6.5.3.1. Scale adjustment for determining level. The levels of the washing solution and high contamination waste bottles are determined by weighing. To adjust the scales, proceed as follows: Washing solution bottle adjustment 1. Put the full washing solution bottle in place. 2. Press the FULL adjustment button. 3. Put the empty washing solution bottle in place.
Page 81 Figure 6.18 Scales adjustment screen 6.5.3.2. Internal bottle verification Detecting the level of the internal bottles containing distilled water and low contamination waste is done through a buoy system. This means that only the analyser can detect whether a bottle is full or empty. The programme enables the status of the buoys to be checked and indicates whether they are full or empty. The status of the buoys for each bottle is shown on the screen (see Figure 6.17). The verification may be made manually or automatically. Manual verification Access the buoys of the internal bottles. To do this, access the internal bottles through the rear part of the analyser and unscrew their caps. Move each buoy upward and downward. The status of each buoy will be constantly shown on the screen. Automatic verification Press the Start button for the programme to perform a full filling and emptying cycle on each bottle. The programme will constantly indicate the status of the buoys. Bear in mind that this automatic verification process may take a few minutes.
Page 82 Service Manual Figure 6.19 Screen for checking the internal bottles. 6.5.4. Verification of the dispensation pumps, pumps and valves. This screen is used to verify the fluidic status of the analyser. The entire fluidic circuit is divided up into functional parts. Each part can be checked with the same buttons. Figure 6.20 Screen for checking the pumps and electro valves 1. Select one of the circuits to be checked (1): • Internal dosing circuit • External washing circuit • Wash station aspiration • Wash station tdispensation • Fluid input/output 2. Select whether you want to perform one cycle or continuous cycles (2) 3. Press the electro valve you want to activate. It will change from grey to green, indicating it is active (3).
Page 83 6. Check in the analyser that the fluids enter and leave, depending on the electro valves and pumps that are activated. 7. On exiting the test, all the electro valves and pumps that are active will be deactivated. 8. In circuits in which a pump and an electro valve are next to each other, when the pump is activated the electro valve will always be activated and when the electro valve is deactivated, the pump will be deactivated. 6.5.5. Adjusting the thermostatting systems Screen for adjusting the thermostatting of the reaction rotor, the reagent tip assembly and for thermostatting the wash station. 6.5.5.1. Wash station thermostatting adjustment The distilled water or washing solution dispensed by the wash station are thermostatted beforehand, to prevent interference with the rotor temperature. The thermostatting adjustment is made in this screen. See Figure 6.19 Follow the steps to execute the adjustment process: 1. Press the adjustment button of section 1 to execute a fluidic conditioning of the system. 2. Remove the rear cover and place the thermometer sensor in the heater measuring point See Figure 6.20 3. Enter the value of the temperature measured with the thermometer in the box of section 2. 4. Press the adjustment button of section 3 to change the regulation system password if the value measured is out of the ranges. Consult chapter AIII to see the ranges accepted in making the wash station heater adjustment. 5. Save the adjustment value. Figure 6.21 Wash station thermostatting adjustment screen...
Page 84 Service Manual Figure 6.22 Point for measuring the wash station heater temperature 6.5.5.2. Adjusting the reaction rotor thermostatting To perform the sample and reagent reactions correctly, the reaction rotor must be at a stable temperature. The reac- tion rotor thermostatting adjustment is made in this screen. See Figure 6.21 Follow the steps to execute the adjustment process: 1. Press the adjustment button of section 1 to execute a fluidic conditioning of the system. This conditioning operation takes about 5 minutes. The rotor can be filled automatically or manually. 2. Place the thermometer sensor in each of the 4 reaction rotor measuring points. Consult Figure 6.22 to see the measuring points. 3. Enter the vale of the temperature measured with the thermometer at each point in each of the boxes of section 2. 4. Press the adjustment button of section 3 to change the regulation system password if the value measured is out of the ranges. Consult AIII to see the accepted ranges in adjusting the reaction rotor. 5. Save the adjustment value.
Page 85 Figure 6.23 Rotor thermostatting adjustment screen Figure 6.24 Reaction rotor measuring points 6.5.5.3. Adjusting the tip thermostatting Reagent tips R1 and R2 suction the reagents from the fridge. Before dispensing the reagent in the rotor, it is ther- mostatted to a temperature that is closer to that of the rotor. The thermostatting of each arm is adjusted in this screen. See Figure 6.23 Follow the steps to execute the adjustment process: 1. Select the arm in which the adjustment is to be made. 2. Press the adjustment button of section 2 to execute a fluidic conditioning of the tip. 3. Place the temperature measuring tool and thermometer sensor in the tip wash station. See Figure 6.24 4. Press the adjustment button of section 3 for the analyser to dispense a volume of water in the wash station. 5. Enter the value of the temperature measured in the box of section 3. Perform several dispensation cyclces to verify that the temperature is stable. 6. Press the adjustment button of section 4 to change the regulation system password if the value measured is out of the ranges.
Page 86 Service Manual Consult AIII to see the accepted ranges in adjusting the tip thermostatting. 7. Save the adjustment value. Figure 6.25 Screen for adjusting the tip thermostatting Figure 6.26 Tool for adjusting the tip thermostatting 6.5.6. Barcode reader adjustment This screen allows you to adjust the positioning of the barcode reader. See Figure 6.25 1. First select the barcode reader you want to adjust. 2. Remove the cover and place a tube or well with a barcode in position 1 of the rotor, to obtain the reference of the beam to be adjusted. 3. Move the rotor step by step with the adjustment box until the reader beam is properly centred on the barcode. 4. Save the adjusted value. 5. Check in section 3 that the reader receives the readings correctly. The indicated value must be higher than 95%. 6. To perform the barcode reader test, place several tubes or bottles in the chosen reader rotor and press the test button of section 4. The table will show the codes of the bars read and the positions in which the tubes/bottles were placed.
Page 87 Figure 6.27 Barcode reader adjustment screen 6.5.7. ISE module This menu is used to launch the different maintenance actions required for the ISE module. The following functions can be executed: • Calibrate • Install a reagent kit • Install the electrodes • Deactivate the module for a long period of time • Change the peristaltic pump tubes • Activate the ISE preparations For each function several actions must be executed. Select one of the functions and show the set of actions to be executed step by step. See the explanation of each step in detail in chapter 14.2.2 of the user manual. Select an action and press the execute button. Information about the action will appear in the results zone. It will say whether the action was successfully completed (the text is shown in black) or has errors (the text is shown in red). The results are shown in the actions that return information, such as calibrations. In addition each of the actions is positioned in a group under the name General; if the user only wants to perform one of the actions, that user can launch it directly. Action Description Maintenance Empties the tubes. Only activates the waste pump. In the repetitions parameter indicate how many times the action must be executed. Bleed A Performs a priming cycle with calibration standard A using a volume of 100 μL. In the repetitions parameter indicate how many times the action must be executed.
Page 88 Service Manual Action Description Priming A Performs a priming cycle with calibration standard A using a volume of 300 μL. In the repetitions parameter indicate how many times the action must be executed. Priming B Performs a priming cycle with calibration standard B using a volume of 300 μL. In the repetitions parameter indicate how many times the action must be executed. Wash Performs a wash cycle with the ISE washing solution. In the sample rotor pos. parameter indicate the position of the tube with the washing solution. In the volume parameter indicate the volume to be dispensed for washing. Activate the reagent Execute this action to activate and memorise the reagent kit in the programme. It is also used to memorise the installation date and record the consumption of the calibration standards. The programme issues a warning when the standards are no longer usable. Activation of Execute this action to activate and memorise the electrodes electrodes in the programme. It is used to record the consumption of the electrodes and warn the user when they are no longer usable. Activation of ISE Use this action to tell the programme you have installed preparations an ISE module. 6.5.8. Stress The stress verification test simulates the normal operating cycle of the analyser. However, instead of pipetting serum and reagent, the analyser moves the arms and pumps, but without pipetting any fluids. The stress can be configured as global stress, i.e., performing a complete cycle or partial stress of functional parts of the analyser. Partial stress options: • Arms (selected separately) • Rotors (selected separately)
Page 89 c) Number of cycles completed d) Number of restarts and cycle in which the restart was executed. This serves to verify whether a power cut occurred in the stress with very long durations. e) Number of errors and description of the error. After a certain number of cycles the analyser performs an internal check to detect whether there are any problems in its operation. For instance, it counts the number of steps in each motor to check that no step has been lost. If any problem is detected, this is shown in the error box. Figure 6.28 Stress screen 6.6. Utilities 6.6.1. Demo mode Enables the analyser to be put in demo mode. This mode performs the basic pipetting and dispensation cycle, which entails a movement of the arms and rotors but no processing of fluids or photometric readings. Press the adjustment button to start the demo mode The analyser will continue performing the demo mode until the stop button is pressed.
Page 90 Service Manual Figure 6.29 Demo mode screen 6.6.2. Analyser information This screen allows you to input or change the analyser serial number. Press the edit button to change the serial number. It also performs the same verification process as the one performed by the analyser when being initialised. Press the “show details” button to see the different steps executed in the verification process. Figure 6.30 Analyser information screen...
Page 91 6.7. Recording and maintenance 6.7.1. Historical reports This screen is used to consult all the actions performed with the service programme. All the actions performed are memorised in a database. To consult the actions, select the filter fields and press search. Filter Description Analyser serial Enter the serial number of the analyser for which the number actions are to be consulted Date Enter the date range through which you want to filter the actions Tasks Select one of the possible tasks: All, Adjustments, test or utilities Actions A list of actions will appear, depending on the chosen task. In the event that many actions have been performed, it is used to view only the chosen action. After selecting the filter fields, the programme displays a table with the filtered information. The user can enter text in the comments column to make a remark about the selection action. Click the inside of the comments box to enter the text. When you have finished, press the save or undo button. IF you want to delete a historical action, select the action and press the delete button. Figure 6.31 Historical information screen 6.7.2. TAS report This screen allows you to write a report for the technical service. Press the “save TASreport” button and a copy of the historical action database will be made automatically. The file generated is located in the following folder: c:\Program Files (x86)\BA400\BA400 Service\SATReports\ It also allows you to delete old TAS Reports.
Page 92 Service Manual 6.8. Exit To exit the programme go to the exit menu and select one of the two options: Exit by switching off the analyser: • This option closes the programme and tells the analyser to switch itself off and complete the closing process. Exit without switching off the analyser • This option will only close the programme and leave the analyser on and on standby.
Page 93 7. Maintenance and cleaning 7.1. Cleaning Material and tools needed to clean the appliance: • Dry air aerosol container or air blower • T20 torx key with a minimum length of 40 mm 7.1.1. Cleaning the interior compartments Every time an operation is performed with the analyser, it is advisable to clean the electronic and fluidic compartments. 1. Remove the side housings 2. Remove the side panels 3. Blow the dust from the electronic boards, components and fans with dry air. 7.1.2. Checking the fluidic connections Check that all the fluidic connections and connections to the electro valves and pumps have no leaks. 1. Remove the side housings 2. Remove the side panels 3. Touch each connection with your hand to verify that the joints are not leaking. 4. Use the service programme to open and close the electro valves and activate the pumps. Ensure there are no fluid leaks in each element when in both states. 7.1.3. Cleaning the water and low contamination waste containers 1. Remove the rear cover.
Page 94 Service Manual 4. Check that the wash station dryer is correctly secured and in good condition. If it is damaged, replace it with a new one. 7.1.5. Cleaning the barcode reader window Wash the inside and outside of the barcode reader window. 1. Remove the top panel of the analyser 2. Use a damp cloth to clean the inside of the two barcode reader windows. 3. Remove the two rotors from their compartments. 4. Clean the outside of the two barcode reader windows with a damp cloth. 7.1.6. Wash the heating canal and the canal of the rotor containers Use a damp cloth and neutral soap. 1. With the analyser switched off, lift the wash station manually. 2. Remove the covers from the 3 rotors. 3. Remove the PMMA rotor and the sample and reagent rotors. 4. Wipe the surface of the heating canal and the inside of the rotor vessel with a cloth. 5. Check that the drains are not blocked. To do this, run some water through the opening and check that the water disappears down the drain.
Page 95 7. Also check that the belt is not worn and that there are no traces of material adhering to the cogs. Check that the anti-collision system of the reagent and sample arms is operating correctly: 1. Remove the top housings from the 3 arms. 2. Initialise the analyser with the service programme 3. Go to the anti-collision system checking option. 4. Lift each tip with your hand and check that they draw back smoothly and correctly. 5. Check that the lamp on the panel goes on every time the tip is in the raised position. 6. Check the indication that the tip is in the raised position in the service programme. Check that the stirrers function correctly: 1. Check that the stirrer blades are properly tightened. Take care when tightening the blades, to ensure they con- tinue to be aligned with respect to the motor shaft. 2. Use the service programme to rotate the stirrers. Check that they rotate correctly and are not eccentric. Check the anti-collision system in the wash station 1. Remove the top housing from the wash station. 2. Initialise the analyser with the service programme 3. Go to the wash station anti-collision system checking option. 4. Lift the dryer tip with your hand and check that it draws back smoothly and correctly. 5. Check the indication that the dryer tip is in the raised position in the service programme. 6. Lift the wash station pedal system with your hand and check that it slides evenly and returns smoothly to its original position. 7.2.3. Checking the sample and reagent rotors Check the rotor covers: 1. Initialise the analyser with the service programme.
Page 96 Service Manual 7.2.4. Inspect the cover and the structure 1. Check that the general fans are functioning correctly. Put your hand on the exterior to verify that they expel air. The general fans have no automatic operation detection system. 2. Check that the wheels have no defects. 3. Check that the analyser is correctly positioned, and that the legs make contact with the floor. Tighten them with a spanner. 4. Check that the analyser is perfectly level with a levelling instrument. Tighten or loosen the legs until the analyser is completely level. Checking the cover and legs: 1. Check that the doors open and close properly and smoothly. Check that they are correctly aligned with each other. 2. Check that the main cover is correctly supported when fully open and that when closing it, it does not fall suddenly. 3. Apply 1 drop of SAE-40 to the rear hinges of the main cover. Open and close the cover several times to help distribute the oil in the hinge. 4. Check the state of the “bumpers” (rubber stops for preventing the main cover from colliding), and if they are worn or damaged, replace them. 7.2.5. ISE module inspection Replace the peristaltic pump tubes every 6 months. Clean the ISE module sample entry opening. Check that the tubes are not blocked.
Page 97 8. Dismantling of elements 8.1. Dismantling of housing The main cover, side housings, doors and rear panel can be removed separately, without having to dismantle the others. To dismantle all the housings and panels, only one tool is required: T20 torx key with a minimum length of 40 mm To dismantle the housings and panels follow the dismantling process in reverse. 8.1.1. Removing the rear cover To remove the rear cover, proceed as follows: 1. Remove the 14 torx screws and their washers (3). 2. Grasp the rear panel (2) using the 2 grips (1). Figure 8.32 Removing the rear cover 8.1.2. Removing the top cover To remove the top cover, proceed as follows: 1. Open the cover and remove the cover sensor tab and the 2 pistons. 2. Close the cover and turn the analyser 3. Remove the 10 torx screws and their washers from the hinges. 4. The cover can now be raised and changed.
Page 98 Service Manual 3. Remove the 3 external screws (). 4. Lift the housing slightly ( ) and remove it from the support. Proceed in the same way to remove the housing on the left side. Figure 8.33 Removing the rear cover 8.1.4. Dismantling and assembling the ISE cover To remove the ISE cover, proceed as follows: 1. Open the ISE cover (1) to access the 2 screws that hold it in place (2). 2. Using an M4 Allen key, remove the 2 screws (2) together with their nuts, washers and the divider. 3. Remove the ISE cover. Figure 8.34 Removing the ISE cover...
Page 99 Proceed as follows to assemble the ISE cover (see Figure 8.4): 1. Assemble the screw, washers, nuts and divider in the cover before reassembling it again on the analyser. 2. Mount both assemblies as shown in Figure 8.4, one on each side of the ISE cover. 3. Do not tighten the nuts. 4. Position the ISE cover on the analyser and slightly tighten the screws (1) on each side. 5. Tighten one screw or the other until the ISE cover is correctly centred. 6. Secure the screw with the Allen key and tighten the nut with a Ford key (3) 7. Repeat the process with the nut (4) Figure 8.35 Detail of installing the ISE cover 8.1.5. Remove the top front housing The top front housing has two parts. Proceed as follows to remove one from the other. Follow the same process to remove the other. 1. Remove the ISE cover. See how to remove the ISE cover in chapter 8.1.4 2. Remove the left side (to remove the left part) 3. Remove the 4 screws from the top tray. 4. Remove the 4 internal screws. 5. Remove the housing. Before removing the housing make sure you have first removed the LED indicator cable. 6. To reassemble the housing, follow the above steps in reverse order. First assembly the LED indicator cable.
Page 100 Service Manual 8.1.6. Dismantling the top tray Figure 8.36 Dismantling the top cover 1. Lift all the arms and the wash station manually. 2. Remove the plastic protective caps (1) from the base of the arms. 3. Remove the plastic cap from the base of the stirrers (4). 4. Remove all the screws (2) securing the cover. 5. Lower the arms manually to the lowest level. 6. Remove the top cover(3). Take care in handling it, as it is very large. 8.2. Remove the sample and reagent arms and the stirrers Figure 8.37 Dismantling the arm assembly 1. Remove the top cover.
Page 101 See chapter 8.1.6 2. Remove the rear cover, to access the interior cables. See chapter 8.1.1 3. Remove the clamps securing the cables and tubes that emerge from the lower part of the arm that you want to dismantle. 4. Remove the 3 screws (1) securing the arm assembly. Use a screwdriver and lengthener to access the screws. 8.3. Dismantling the reagent rotor 1. Remove the top cover. See chapter 8.1.6 2. Unplug the 5 fans connected to the CIIM00052 board 3. Unplug the two CAN cables connected to the CIIM00052 board 4. Remove the reagent 2 arm, to leave sufficient space for taking out the rotor. See chapter 8.2 5. Loosen the 5 screws securing the rotor assembly to the base. See Figure 8.7 6. Remove the rotor assembly and follow the steps indicated in Figure 8.8 to take the rotor out of the analyser. Figure 8.38 Rotor anchoring screws...
Page 102 Service Manual Figure 8.39 Movements required to take the rotor out of the analyser 8.4. Dismantling the sample rotor 1. Remove the top cover. See chapter 8.1.6 2. Unplug the 2 fans connected to the CIIM00052 board 3. Unplug the CAN cable. 4. Remove the sample arm See chapter 8.2 5. Loosen the 4 screws securing the rotor assembly to the base. See Figure 8.9 6. Loosen the screw that secures the wash station housing 7. Disconnect all the wash station tubes and take them from the housing 8. Remove the rotor assembly and follow the steps indicated in Figure 8.10 to take the rotor out of the analyser. Figure 8.40 Movements required to take the rotor out of the analyser...
Page 103 Figure 8.41 Movements required to take the rotor out of the analyser 8.5. Dismantling the reaction rotor 1. Remove the top cover. See chapter 8.1.6 2. Unplug the CAN cable. 3. Remove the stirrer 2 arm See chapter 8.2 4. Remove the sample rotor See chapter 8.4 5. Loosen the 5 screws shown in Figure 8.11 6. Take the rotor assembly out of the analyser Figure 8.42 Reaction rotor anchoring screws...
Page 104 Service Manual 8.6. ISE module installation The ISE module is optional. To install the ISE module, proceed as follows: The spares content is as follows: Component Description Power supply Switch Cabling Cable gland Connector and tubes ISE module 1. Remove the side housings. 2. Remove the top cover. Remove from the cover the opening plug for dispensing the ISE module sample(8). See Figure 8.14 3. Dismantle the top front housings together with the ISE cover (7) 4. Dismantle the switch assembly (2). See Figure 8.12 5. Remove the switch cover (1) 6. Insert the ISE switch. 7. Connect the power cable to the switch. 8. Close the switch assembly with the protective cover (3) and put it back in place. See Figure 8.13.
Page 105 Figure 8.43 Dismantling the switch assembly 9. Lower the cabling through the analyser column (4). See Figure 8.13. 10. Install the power supply (5) as shown in the previous figure. 11. Connect one of the cable ends to the power supply. 12. Connect the other end to the AC distribution board (6). 13. Connect the module power cables to the power supply output. These cables are already installed in the analyser. 14. Insert the module in its compartment. See Figure 8.15. Use the same screws that secure the cover to screw the module in place. 15. Place the pincer (9) of the calibration standard kit in the compartment located next to the internall bottles. See Figure 8.16 16. Pass the tubes through the two openings (10) and (11) until they reach the module. 17. Consult the user manual chapter on installing the ISE module to see how to connect the different tubes and install the electrodes and standard kit. 18. Replace all the covers and housings. 19. Install the cable gland in the sample dispensing opening in the top cover...
Page 106 Service Manual Figure 8.44 ISE module power supply installation Figure 8.45 Location of the covers...
Page 107 Figure 8.46 ISE module assembly Figure 8.47 Tube installation...
Page 108 Service Manual AI. List of accessories and spares In the event of any of the analyser components being damaged or if any fungible goods are required, always use original BioSystems material. The following table shows a list of the components that might be needed. To purchase them contact your habitual distributor and ask for each element with its respective code. LIST OF ACCESSORIES CODE REPRESENTATION DESCRIPTION AC16 359 DVD with User Programme AC11 485 “Reaction Rotor” (10) AC10 770 “Sample wells” (1 000) AC16 434 500 mL bottle of concentrated washing solution AC16 360 Open adapter for primary tubes (90) AC16 361 Closed adapter for sample wells (45) AC16 362 60mL reagent bottles (20)
Page 109 LIST OF ACCESSORIES CODE REPRESENTATION DESCRIPTION AC16 363 20mL reagent bottles (20) AC16 364 60mL brown reagent bottles (20) AC16 365 20mL brown reagent bottles (20) AC16 366 Connection tube for distilled water bottle (3 m) AC16 367 Connection tube for waste (3 m) AC16 368 Washing solution bottle with cap AC16 369 High contamination bottle with cap...
Page 110 Service Manual LIST OF ACCESSORIES CODE REPRESENTATION DESCRIPTION AC16 370 Reagent rotor AC16 371 Sample rotor AC11 486 Reaction rotor set screw CA10 455 European mains cable CA10 456 American mains cable FI10 466 Serial channel cable for connection to PC FI14 226 USB cable for connection to PC LIST OF ISE MODULE ACCESSORIES (OPTIONAL) CODE REPRESENTATION DESCRIPTION ME5420 Reagent pack...
Page 111 LIST OF ISE MODULE ACCESSORIES (OPTIONAL) CODE REPRESENTATION DESCRIPTION ME5625 Tube assembly ME5201 electrode ME5202 electrode ME5207 electrode ME5205 electrode ME5204 Separator electrode ME5204 Reference electrode ME5421 ISE module washing solution KIT ME5412 ISE 125mL urine dilution module...
Page 112 Service Manual LIST OF SPARES PARTS Code Representation Description DVD Service programme and Service Manual AC16534 Reaction rotor screw AC16535 Reaction rotor cover AC16536 Sample rotor cover AC16537 Reagent rotor cover AC16538 Arm cover AC16539 Top cover of wash station AC16540 Lower cover of wash station AC16541 Lower cover of arm AC16542 Lower cover of stirrers...
Page 113 LIST OF SPARES PARTS Code Representation Description AC16543 ISE module cover AC1644 Door assembly AC16545 Lateral cover assembly AC16546 Rear cover handles AC16547 Reagent and sample rotor frame joint AC16549 Hinger of general cover AC16550 Front led frame AC16551 Legs...
Page 114 Service Manual LIST OF SPARES PARTS Code Representation Description AC16552 Wheels AC16553 Filter and network connector AC16554 Switch assembly AC16555 CPU board AC16556 Distribution board AC16557 Arm board AC16558 Tip board AC16559 Photometry Control Board AC16560 Photometry board AC16561 Sample rotor board...
Page 115 LIST OF SPARES PARTS Code Representation Description AC16562 Reagent rotor board AC16563 Fluid board AC16564 Syringe board AC16565 Photobarrier board AC16634 AC input board AC16566 Led Manifold Board AC16567 320 W power supply AC16569 35 W power supply AC16570 Load cell...
Page 116 Service Manual LIST OF SPARES PARTS Code Representation Description AC16571 General fan (2 wires) AC16572 Distilled water bottle with cap and buoys AC16573 Low contamination waste bottle with cap and buoys AC16574 Tip wash station AC16575 Reaction rotor support column AC16576 Manifold assembly AC16577 Wash station heater AC16578 3-way electro valve...
Page 117 LIST OF SPARES PARTS Code Representation Description AC16579 Pre dose Manifold AC16580 Water inlet valve AC16581 Dispensing pumps AC16582 Suction pumps AC16583 External water inlet adapter AC16584 Water tank inlet adapter AC16585 Wash station pump stop + O-ring AC16586 Wash station pump motor AC16587 Top chamber AC16588 Piston support + pistons...
Page 118 Service Manual LIST OF SPARES PARTS Code Representation Description AC16589 Manifold AC16590 Reagent piston stop AC16591 Sample piston stop AC16592 Pump motor+spindle AC16593 Sample ceramic piston AC16594 Reagent ceramic piston AC16595 Wash station suction tip AC16596 Wash station suction tip+dryer AC16597 Wash station tip spring AC16598 Vertical movement belt AC16599 Polar movement belt AC16600 Arm motor AC16601 Contintuous current stirrer motor AC16602 Stirrer paddle...
Page 119 LIST OF SPARES PARTS Code Representation Description AC16603 Sample tip AC16604 Reagent tip AC16605 Tip spring AC16606 340 Filter AC16607 405 Filter AC16608 505 Filter AC16609 535 Filter AC16610 560 Filter AC16611 600 Filter AC16612 635 Filter AC16613 670 Filter AC16614 Optical bench without filters AC16615 Reaction rotor cogged belt...
Page 120 Service Manual LIST OF SPARES PARTS Code Representation Description AC16616 Reaction rotor motor AC16617 Rotor centring device AC16618 Wash station elevation motor AC16619 Wash station vertical movement belt AC16620 Reaction rotor temperator sensor AC16621 Reaction rotor thermostatting fan assemblyl (3 wires) AC16622 Reaction rotor peltier assembly AC16623 Reaction/sample rotor motor...
Page 121 LIST OF SPARES PARTS Code Representation Description AC16624 Reagent rotor cogged belt AC16625 Barcode reader AC16626 Refrigerator fan assembly (3 wires) AC16627 Refrigerator peltier assembly AC16628 Barcode window heater...
Page 122 Service Manual LIST OF SPARES PARTS Code Representation Description AC16629 Barcode reader window AC16630 Cover sensor AC16631 Refrigerator temperature sensor AC16632 Reagent or sample rotor centring device AC16391 ISE module Instruments.and.tools Code Representation Description AC16643 Adjustment instruments AC16644 Adjustment screwdriver for level detection AC16645 Allen key lengthener assembly...
Page 123 AII. Technical characteristics The manufacturer declines all liability for damages caused by using the appliance incorrectly. WARNING GENERAL CHARACTERISTICS Speed 400 prep/h (without electrolytes) ISE module speed 320 prep/h Analysis principles Colorimetry, turbidimetry. ISE module: Potentiometry (selective electrode method): Na , Cl (Li is optional) SAMPLE CONTROL Sample rotor capacity Barcode detector Number of samples with barcodes Size of primary tubes Diameter 12 mm to 16 mm (max. height 100 mm) Sample well Sample well diameter 13.5 mm Type of sample pump syringe Low-maintenance ceramic piston Piston diameter 3 mm Pipetting volume 2 μL to 40 μL Pipetting resolution 0.1 μL Maximum ratio between sample and reagent volume 1:2 to 1:200 Level detection Washing of tip Interior and exterior Clot sensor Vertical collision detector...
Page 124 Service Manual REAGENT CONTROL Pipetting resolution 1 mL Level detection Washing of tip Interior and exterior Vertical collision detector Thermostatted tip REACTION ROTOR Minimum reaction volume 200 μL Maximum reaction volume 600 μL Number of cuvettes Cuvette material UV methacrylate Type of incubation Fixed dispensing time for 2nd reagent 5 min (fixed) Reaction cuvette temperature 37 °C Temperature accuracy ±0.2° C Temperature stability ±0.1° C Stirrers CUVETTE WASHING SYSTEM Number of washing system tips Number of tips with washing solution Rinsing with water Drying Washing volume 711 μL Washing solution consumption 1.42 mL/cycle OPTICAL SYSTEM Light source...
Page 125 ISE MODULE (optional) Sample volume Serum: 100 mL Urine: 200 mL ENVIRONMENTAL REQUIREMENTS Room temperature 10° C to 35° C 10° C to 30° C (with ISE module) Relative humidity < 85% with no condensation Maximum height < 2 500 m Contamination grade Transportation and storage temperature 0° C to 40° C Transportation and storage humidity < 85% with no condensation DIMENSIONS AND WEIGHT Dimensions (Width, depth and height) 1200 mm x 720 mm x 1258 mm Weight 210 kg ELECTRICITY REQUIREMENTS Mains voltage 115 V to 230 V Network frequency 50 Hz or 60 Hz Electric power 500 VA FLUID REQUIREMENTS Water inlet Through external tank or through direct connection Type of water Purified type II (NCCLS) Water consumption...
Page 126 Service Manual AIII. Adjustment margin tables Adjustment margins: Parameter Minimum Maximum Reading reference position - Well 1 7 860 7 905 Washing solution tare 0 Washing solution tare 50 Washing solution tare 100 Washing solution tare 150 Waste tare 0 Waste tare 50 Waste tare 100 Waste tare 150 Thermal adjustment of reaction rotor 37,0 39,0 Thermal adjustment of wash station 44,0 50,0 Thermal adjustment of reagent tip 1 50,0 55,0 Thermal adjustment of reagent tip 2 50,0 55,0 Thermal test on reaction rotor 36.8 37,2 Thermal test on wash station 45,0 50,0 Thermal test on reagent tip 1 30,0 35,0 Thermal test on reagent tip 2...
Page 127 Number of counts of main photodiode Minimum Maximum Wavelength 560 550 000 950 000 Wavelength 600 750 000 950 000 Wavelength 635 850 000 950 000 Wavelength 670 450 000 950 000 Number of counts of reference Minimum Maximum photodiode Wavelength 340 100 000 400 000 Wavelength 405 400 000 800 000 Wavelength 505 400 000 800 000 Wavelength 535 400 000 800 000 Wavelength 560 400 000 950 000 Wavelength 600 300 000 800 000 Wavelength 635 400 000 800 000 Wavelength 670 200 000 950 000...
Page 128 Service Manual AIV. Software versions Changes in the service programme versions Date Versions Changes 15/05/12 1.0 First version Changes in the user programme versions Date Versions Changes 15/05/12 1.0 First version Changes in the firmware versions Date Versions Changes 15/05/12 1.0 first version...
Page 129 • Useful life: There is no limit on the useful life, provided the manufacturer's instructions regarding use and maintenance set out in the User Manual are complied with and original spares are used. BioSystems will maintain the spares service up to 5 years after the manufacture of the same model of the last analyser. • Number of times the appliance can be repackaged: There is no limit regarding the number of times it can be repackaged, provided the repackaging instructions described in this section are complied with and original spares are used. • Accessories used in repackaged appliances: All repackaged analysers will use the accessories supplied by the manufacturer. Any remains of surplus fungibles used previously such as rotors, spare reagent or washing solu- tion bottles, etc. will be disposed of. Personnel: The repackaging operation will be carried out by personnel authorised by Biosystems. This person- • nel will normally be the dealer's technical service staff or persons who have received the appropriate training. Instructions Cleaning and desinfecting Users carrying out disinfection processes must wear gloves and protective apparel. All consumable materials (reaction rotor, reagent bottles, sample tubes) will be treated as potentially infectious waste. Check whether there are any reaction rotors in their compartments or reagent bottles in the refrigerator. If there are, dispose of them. Empty the high contamination waste tank and washing solution tank. Wash the inside of the equipment using a damp cloth and neutral soap. If there are splashes, wash them with alcohol. Follow the applicable national guidelines for disposing of waste that is considered potentially infectious. Components to be replaced Replace the following components: • Wash station suction tubes...
Page 130 Service Manual • Photometry test formula18 formula19 Execute with the user programme. To make the functional check, use the following BioSystems reagents and reference materials: • Glucose reagent (12503) • ALT reagent (12533) • Multi-standard serum (18011) • Level I and II control serum (18009 and 18010) Change the following parameters in the glucose and ALT test programmes: Number of replicates: 20 Multistandard concentration: Enter the value. Programme the following list: Two patients called: Level I and Level II Programme the tests for each patient: Glucose and ALT Execute the list. The analyser will perform the blank, standard and 20 replicates at each control serum level. Once it has finished it will display the results. Calculate the CV for each result with the 20 replicates. The CV is calculated as:  ∑  x −Media CV = ⋅100 Media n−1 Check that the results are within the margins: Biochemical precision CV (%) Control serum Level I glucose < 2...
Page 131 • An indication that it is a renovated appliance Useful life: no limit, provided the manufacturer's instructions regarding use and maintenance are followed. Add a new box of accessories. Use the original packaging. First check its state and if it is clearly damaged, replace with a new one. Send the completed record to the Biosystems technical service (in pdf format).
Page 132 REPACKAGING RECORD Company name: 340 nm 100 000 400 000 Serial number: 405 nm 400 000 800 000 Repackaging date: 505 nm 400 000 800 000 535 nm 400 000 800 000 PART REPLACEMENT PROCESS 560 nm 400 000 950 000 600 nm 300 000 800 000 1. Parts to be replaced 635 nm 400 000 800 000 Replacement of parts Ok / Not Ok 670 nm 200 000 950 000 Update the firmware 4.4. Dark current counts Ok / Not Ok and software Value 3 300 4 500 4.5. Repeatability Tolerances CV(%) ADJUSTMENT PROCESS...

biosystems BA 400 Service Manual

Quick Links

Need help?

Questions and answers

Subscribe to Our Youtube Channel

Related Manuals for biosystems BA 400

Summary of Contents for biosystems BA 400